Patient interface including flow generator

Abstract

A patient interface for treating patients with respiratory diseases includes an RPT device including an electric blower configured to produce pressurized breathable air; a user interface structure configured to engage with the patient's face and at least partially form a plenum chamber configured to receive pressurized breathable air; a head-mounted interface configured to substantially cover the patient's eyes; a flow generator casing at least partially surrounding the head-mounted interface and the electric blower and connected to the plenum chamber, the flow generator casing including at least one air opening for receiving ambient air to be delivered to the RPT device; and a positioning and stabilizing structure configured to maintain the user interface structure in a therapeutically effective position.

Description

Technical Field

[0001] Part of the disclosure of this patent document contains content that is subject to copyright protection. The copyright owner has no objection to anyone copying this patent document or this patent disclosure for purposes described in the patent files or records of the Patent Office, but retains all copyrights for other purposes.

[0002] (Cross - reference to related applications) This application claims the priority of U.S. Provisional Application No. 63 / 463,729, filed on May 3, 2023, the entire content of which is incorporated herein by reference.

[0003] Also, PCT Application No. PCT / AU2022 / 051321, filed on November 4, 2022, is incorporated herein by reference in its entirety.

[0004] (Technical Field) This technology relates to one or more of screening, diagnosis, monitoring, treatment, prevention, and improvement of respiratory - related diseases. This technology also relates to medical devices or apparatuses, and their use.

[0005] This technology also generally relates to head - mounted displays, positioning and stabilization structures, user interface structures, and other components for use in head - mounted displays, display units, and related head - mounted display assemblies and systems, including positioning and stabilization structures, interface structures, and / or components, as well as methods. This technology is particularly applied in the use of virtual reality head - mounted displays and is described herein in that context. However, it is understood that this technology has a broader scope of application and can be used in other head - mounted display configurations, including augmented reality displays.

Background Art

[0006] 2.2.1 Human respiratory system and its diseases The body's respiratory system facilitates gas exchange. The nose and mouth form the entrance to the patient's airway.

[0007] These airways contain a series of branch tubes, which become narrower, shorter, and more numerous as they extend deeper into the lungs. The primary function of the lungs is gas exchange, enabling oxygen to move from inhaled air to venous blood and carbon dioxide to move in the opposite direction. The trachea divides into the right and left main bronchi, which further divide into terminal bronchioles. The bronchi constitute the airways for conduction and are not involved in gas exchange. Further division of the airways results in respiratory bronchioles, which eventually become alveoli. Gas exchange takes place in the alveolar region of the lungs, and this region is called the respiratory region. See *Respiratory Physiology*, 9th edition, 2012, by John B. West, Lippincott Williams & Wilkins.

[0008] A wide range of respiratory disorders exist. Specific disorders can be characterized by specific onsets (e.g., apnea, hypopnea, and hyperventilation).

[0009] Examples of respiratory diseases include obstructive sleep apnea (OSA), Cheyne-Stokes respiration (CSR), respiratory dysfunction, obesity hypoventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular diseases (NMD), and chest wall diseases.

[0010] Obstructive sleep apnea syndrome (OSA), a type of sleep-disordered breathing (SDB), is characterized by obstruction or blockage of the upper airway during sleep. This is a result of a combination of an abnormally small upper airway, normal loss of muscle tone in the tongue region, and normal loss of the soft palate and posterior oropharyngeal wall during sleep. As a result, respiratory cessation in affected individuals typically lasts 30 to 120 seconds, sometimes as many as 200 to 300 times a night. Consequently, excessive daytime sleepiness occurs, and it can contribute to cardiovascular disease and brain injury. This syndrome is a common disorder, particularly prevalent in overweight middle-aged men, but patients often have no subjective symptoms. See U.S. Patent No. 4,944,310 (Sullivan) for more information.

[0011] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a disorder of the patient's respiratory regulator, characterized by alternating, cyclical increases and decreases in ventilation known as CSR cycles. CSR is characterized by repeated deoxygenation and re-aeration of arterial blood. Due to repeated hypoxia, CSR can be harmful. In some patients, CSR is associated with repeated awakenings from sleep, resulting in severe insomnia, increased sympathetic activity, and increased afterload. See U.S. Patent No. 6,532,959 (Berthon-Jones).

[0012] Respiratory failure is a general term for respiratory diseases in which the lungs are unable to adequately inhale oxygen or exhale CO2 to meet the patient's needs. Respiratory failure may encompass some or all of the following conditions:

[0013] Patients with respiratory failure (a type of respiratory failure) may experience abnormal shortness of breath during exercise.

[0014] Obesity hyperventilation syndrome (OHS) is defined as a combination of severe obesity and chronic hypercapnia while awake, in the absence of other clearly identifiable causes of hypoventilation. Symptoms include shortness of breath, morning headache, and excessive daytime sleepiness.

[0015] Chronic obstructive pulmonary disease (COPD) encompasses a group of lower respiratory tract diseases that share certain common characteristics. These include increased resistance to air movement, prolonged expiratory phase of breathing, and reduced normal elasticity in the lungs. Examples of COPD include emphysema and chronic bronchitis. COPD is caused by chronic smoking (a major risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include shortness of breath on exertion, chronic cough, and sputum production.

[0016] Neuromuscular diseases (NMDs) are a broad term encompassing numerous illnesses and diseases that impair muscle function, either directly or indirectly through intrinsic muscle pathology. Some NMD patients are characterized by progressive muscle damage that leads to loss of walking ability, wheelchair use, dysphagia, respiratory muscle weakness, and ultimately death from respiratory failure. Neuromuscular disorders can be classified into rapidly progressive and slowly progressive: (i) Rapidly progressive disorders: characterized by muscle damage that worsens over months and leads to death within years (e.g., amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in teenagers); (ii) Variable or slowly progressive disorders: characterized by muscle damage that worsens over years and only slightly reduces life expectancy (e.g., limb-girdle, facioscapulohumeral, and myotonic muscular dystrophy). Symptoms of NMD respiratory failure include worsening general weakness, dysphagia, shortness of breath during exertion and at rest, fatigue, drowsiness, morning headache, and difficulty with attention and emotional changes.

[0017] Chest wall disorders are a group of thoracic deformities that result in inefficient connections between the respiratory muscles and the rib cage. These disorders are primarily characterized by restrictive disorders and share the potential for long-term excess carbon dioxide respiratory failure. Scoliosis and / or kyphosis can develop into severe respiratory failure. Symptoms of respiratory failure include exertional dyspnea, peripheral edema, orthopnea, recurrent chest infections, morning headaches, fatigue, poor sleep quality, and loss of appetite.

[0018] A range of therapies have been used to treat or improve this condition. Furthermore, healthy individuals may utilize such treatments to prevent the onset of respiratory problems in other areas. However, these methods have several shortcomings. 2.2.2 Therapy

[0019] A variety of respiratory therapies (e.g., continuous positive airway pressure (CPAP), non-invasive ventilation (NIV), invasive ventilation (IV), and high-flow therapy (HFT)) are used to treat one or more of the respiratory disorders described above. 2.2.2.1 Respiratory pressure therapy

[0020] Respiratory pressure therapy is the application of supplying air to the airway entrance at a controlled target pressure that maintains nominal positive pressure relative to the atmosphere throughout the patient's entire respiratory cycle (in contrast to negative pressure therapy, such as tank ventilators or positive / negative pressure external ventilators (cuirass)).

[0021] Continuous positive airway pressure (CPAP) therapy is used in the treatment of obstructive sleep apnea (OSA). Its mechanism of action involves, for example, pushing the soft palate and tongue forward or backward against the posterior oropharyngeal wall, allowing CPAP to function as an air splint, thereby preventing upper airway obstruction. Since CPAP therapy for OSA is sometimes optional, patients may choose not to follow the therapy if they find one or more of the devices used to provide this therapy uncomfortable, difficult to use, expensive, or unsightly.

[0022] Non-invasive ventilation (NIV) provides ventilatory support to a patient via the upper airway to assist the patient's breathing and / or maintain adequate oxygen levels in the body by completing some or all of the respiratory task. Ventilation support is provided through a non-invasive patient interface. NIV is used to treat forms of respiratory failure and pulmonary stenosis such as OHS, COPD, NMD, and chest wall disorders. In some forms, the comfort and effectiveness of these therapies can be improved.

[0023] Invasive ventilation (IV) supports ventilation for patients who are no longer able to breathe effectively on their own and may be provided using a tracheostomy tube or an endotracheal tube. In some forms, the comfort and effectiveness of these therapies can be improved. 2.2.2.2 Flow therapy

[0024] In all respiratory therapies, delivery of a defined therapy pressure is not necessarily intended. Some respiratory therapies aim to deliver a predetermined tidal volume by delivering an inspiratory flow profile that overlaps as much as possible with a positive baseline pressure over a target period. In other cases, the interface to the patient's airway is "open" (seal released), and the respiratory therapy can complement only the patient's spontaneous breathing with a regulated gas or enriched gas flow. In one example, high-flow therapy (HFT) is to provide a continuous, heated, humidified air flow at a "therapy flow" that can be maintained substantially constant throughout the respiratory cycle through a patient interface that is seal-released or open at the airway inlet. The therapy flow is nominally set to exceed the patient's peak inspiratory flow. HFT is used for the treatment of OSA, CSR, respiratory insufficiency, COPD, and other respiratory disorders. One mechanism of action is that high-flow air at the airway inlet improves ventilation efficiency by flushing or pushing out CO2 exhaled from the patient's anatomic dead space. Therefore, HFT may be referred to as dead space therapy (DST). Other benefits include improved warmth and humidification (perhaps due to the benefit of secretion control) and the possibility of a gentle increase in airway pressure. As an alternative to a constant flow, the therapy flow can follow a profile that varies over the respiratory cycle.

[0025] Another form of flow therapy is long-term oxygen therapy (LTOT) or oxygen supplementation therapy. A physician may prescribe a continuous flow of oxygen-enriched air at a specific oxygen concentration (from the fraction of oxygen in ambient air, 21% to 100%) delivered to the patient's airway at a specific flow rate (e.g., 1 liter per minute (LPM), 2 LPM, 3 LPM, etc.). 2.2.3 Respiratory Therapy System

[0026] These respiratory therapies may be provided by a respiratory therapy system or device. Such systems and devices may also be used to screen, diagnose, or monitor a disease without performing treatment.

[0027] A respiratory therapy system may include a respiratory pressure therapy device (RPT device), an air circuit, a humidifier, a patient interface, an oxygen source, and data management. 2.2.3.1 Patient Interface

[0028] The patient interface may be used to provide an interface to the wearer as a breathing apparatus, for example by providing an air flow to the entrance to the airway. The air flow may be provided via a mask to the nose and / or mouth, a tube to the mouth, or a tracheostomy tube to the patient's trachea. Depending on the therapy applied, the patient interface may promote gas delivery at a pressure sufficiently different from ambient pressure, for example a positive pressure of about 10 cmH2O relative to ambient pressure, by forming a seal with a part of the patient's face, and may effectively perform the therapy. In the case of other treatment modalities such as oxygen delivery, the patient interface may be sufficient to promote the delivery of gas supply to the airway at a positive pressure of about 10 cmH2O. 密封性 In the case of flow therapy such as nasal HFT, the patient interface is configured to deliver air to the nostrils (and clearly avoid a complete seal). An example of such a patient interface is a nasal cannula.

[0029] Certain other mask systems may be functionally unsuitable in this field. For example, purely decorative masks may not be able to maintain adequate pressure. Mask systems used for underwater swimming or diving may be configured to protect against water ingress from higher external pressures but not to maintain internal air at pressures higher than the ambient pressure.

[0030] Certain masks may be clinically disadvantageous to this technology, such as those that block airflow through the nose while allowing airflow only through the mouth.

[0031] In certain masks, if the patient must insert a portion of the mask structure into their mouth and create and maintain a seal through their lips, this technology may be uncomfortable or impractical.

[0032] Certain masks may be impractical for use while sleeping (for example, when sleeping on your side in bed with your head on a pillow).

[0033] Designing patient interfaces presents several challenges. The face has a complex three-dimensional shape. The size and shape of the nose and head vary greatly from person to person. Because the head contains bone, cartilage, and soft tissue, different areas of the face respond differently to mechanical forces. That is, the jaw or mandible can move relative to other bones of the skull. The entire head can move throughout the respiratory treatment period.

[0034] Due to these challenges, some masks, especially when worn for extended periods or when the patient is unfamiliar with the system, may be intrusive, aesthetically undesirable, expensive, poorly fitting, difficult to use, and uncomfortable for one or more reasons. Incorrectly sized masks can lead to decreased compliance, reduced comfort, and worsened patient outcomes. While pilot masks, personal protective equipment (e.g., filter masks), masks designed as part of SCUBA masks, or masks used for anesthesia may be tolerable for their original purpose, they can be undesirable for prolonged wear (e.g., several hours). This discomfort can lead to decreased patient compliance with treatment, especially when wearing the mask during sleep.

[0035] CPAP therapy is highly effective in treating certain respiratory conditions, provided the patient consents to the treatment. Patients may not adhere to the treatment if the mask is uncomfortable or difficult to use. Since patients are often advised to clean their masks regularly, if the mask is difficult to clean (e.g., difficult to assemble or disassemble), patients may be unable to clean it, which can affect their compliance.

[0036] Masks designed for other purposes (e.g., for pilots) may be unsuitable for treating sleep-disordered breathing, while masks designed for treating sleep-disordered breathing may be suitable for other purposes.

[0037] For these reasons, patient interfaces for CPAP delivery during sleep form a distinct field. 2.2.3.1.1 Seal-forming structure

[0038] The patient interface may include a seal-forming structure. Since the patient interface comes into direct contact with the patient's face, the shape and configuration of the seal-forming structure can directly affect the effectiveness and comfort of the patient interface.

[0039] Patient interfaces can be partially characterized according to the design intent of where the seal-forming structure engages with the face during use. In one embodiment of a patient interface, the seal-forming structure may include a first sub-part for forming a seal around the left nostril and a second sub-part for forming a seal around the right nostril. In one embodiment of a patient interface, the seal-forming structure may include a single element that surrounds both nostrils during use. Such a single element may be designed to rest, for example, on the upper lip region and nasal bridge region of the face. In one embodiment of a patient interface, the seal-forming structure may include an element that surrounds the mouth region during use by forming a seal, for example, on the lower lip region of the face. In one embodiment of a patient interface, the seal-forming structure may include a single element that encloses both nostrils and the mouth region during use. These different types of patient interfaces may be known by a variety of names by their manufacturers, such as nasal masks, full-face masks, nasal pillows, nasal puffs, and mouth-nasal masks.

[0040] For example, due to the different shapes, structures, variability, and sensitive areas of a patient's face, a seal-forming structure that may be effective in one area of ​​the patient's face may be unsuitable in another. For instance, a seal on swimming goggles that rests on a patient's forehead may be unsuitable for use over the patient's nose.

[0041] A specific seal-forming structure can be designed for mass production so that a single design fits a wide range of different face shapes and sizes, ensuring comfort and effectiveness. To form a seal, one or both the patient's facial shape and the mass-produced patient interface seal-forming structure must be adapted to a certain extent, even if there is some mismatch between them.

[0042] One type of seal-forming structure extends around the patient interface and is intended to seal the patient's face when a force is applied to the patient interface while the seal-forming structure is engaged with the patient's face. This seal-forming structure may include an air or fluid-filled cushion, or it may include a molded or formed surface of an elastic sealing element made of an elastomer such as rubber. In this type of seal-forming structure, if the fit is insufficient, a gap exists between the seal-forming structure and the face, requiring additional force to press the patient interface against the face to achieve a seal.

[0043] Another type of seal-forming structure uses a thin flap seal positioned around the perimeter of the mask to provide a self-airtight seal against the patient's face when positive pressure is applied inside the mask. Similar to the previously mentioned types of seal-forming structures, if the fit between the face and the mask is poor, additional force may be required to achieve a seal, or leakage may occur from the mask. Furthermore, if the shape of the seal-forming structure does not match the shape of the patient, it may wrinkle or buckle during use, potentially leading to leakage.

[0044] Other types of seal-forming structures may include, for example, friction-fitting elements inserted into the nostrils, but some patients may find these seal-forming structures uncomfortable.

[0045] Another form of seal-forming structure may use adhesive to achieve a seal. Some patients may find it inconvenient to constantly attach or remove the adhesive to their face.

[0046] A series of patient interface seal formation structures technologies are disclosed in the following patent applications, which have been transferred to ResMed: WO 1998 / 004310, WO 2006 / 074513, and WO 2010 / 135785.

[0047] One form of nasal pillow is found in the Adam circuit manufactured by Puritan-Bennett. Another nasal pillow, or nasal puff, is protected by U.S. Patent No. 4,782,832 (Trimble et al.), which was transferred to Puritan-Bennett Corroration.

[0048] ResMed manufactures the following products that incorporate a nasal pillow: SWIFT™ Nasal Pillow Mask, SWIFT™ II Nasal Pillow Mask, SWIFT™LT Nasal Pillow Mask, SWIFT™FX Nasal Pillow Mask, and MIRAGE LIBERTY™ Full Face Mask. The following patent applications, assigned to ResMed Limited, describe examples of nose pillow masks: International Patent Application WO2004 / 073, 778 (in particular, describing the features of ResMed Limited's SWIFT® nose pillow); U.S. Patent Application 2009 / 0044808 (in particular, describing the features of ResMed Limited's SWIFT® LT nose pillow); International Patent Applications WO2005 / 063, 328 and WO2006 / 130, 903 (in particular, describing the features of ResMed Limited's MIRAGE LIBERTY® full-face mask); International Patent Application WO2009 / 052, 560 (in particular, describing the features of ResMed Limited's SWIFT® FX nose pillow). 2.2.3.1.2 Positioning and Stabilization

[0049] The seal-forming structures of patient interfaces used in positive pressure air therapy are subjected to corresponding forces from the air pressure that can disrupt the seal. Therefore, various techniques are employed to position the seal-forming structures and maintain a seal over the appropriate portion of the face.

[0050] In one technology, adhesive joints are used. See, for example, U.S. Patent Application Publication No. 2010 / 0000534. However, the use of adhesive joints can sometimes cause discomfort.

[0051] In other technologies, one or more straps and / or stabilization harnesses are used. In many such harnesses, one or more of the following apply: poor fit, bulkiness, discomfort, and difficulty of handling. 2.2.3.2 Respiratory Pressure Therapy (RPT) Devices

[0052] Respiratory pressure therapy (RPT) devices may be used alone or as part of a system to impart one or more of the above-mentioned therapies by, for example, activating the device to generate an airflow and delivering it to an interface with the airway. The airflow may be pressure-controlled (in the case of respiratory pressure therapy) or flow-controlled (in the case of flow therapy such as HFT). Therefore, RPT devices can also function as flow therapy devices. Examples of RPT devices include CPAP devices and ventilators.

[0053] Pneumatic generators are well known in a wide range of applications (e.g., industrial-scale ventilation systems). However, pneumatic generators for medical applications have specific requirements that cannot be satisfied by more general pneumatic generators (e.g., reliability, size, and weight requirements for medical devices). In addition, even devices designed for medical treatment may not be free from defects related to one or more of the following: comfort, noise, ease of use, effectiveness, size, weight, manufacturability, cost, and reliability.

[0054] One example of a specific requirement for a particular RPT device is acoustic noise.

[0055] [Table 1]

[0056] One known RPT device used in the treatment of sleep-disordered respiratory disorders is the S9 Sleep Therapy System (manufactured by ResMed Limited). Another example of an RPT device is a ventilator. Ventilators (e.g., the ResMed STella® series of ventilators for adults and children) can treat a number of diseases (to name few, NMD, OHS, and COPD) by providing assistance for invasive and non-invasive, independent ventilation in a variety of patients.

[0057] The ResMed Elisee® 150 and ResMed VSIII® ventilators can provide invasive and non-invasive dependent ventilation assistance suitable for adult or pediatric patients for the treatment of multiple diseases. These ventilators offer volumetric ventilation and pneumatic ventilation modes using single-branch or double-branch circuits. RPT devices typically include a pressure generator (e.g., an electric blower or compressed gas reservoir) configured to supply airflow to the patient's airway. In some cases, the airflow may be supplied to the patient's airway under positive pressure. The outlet of the RPT device is connected to a patient interface as described above via an air circuit.

[0058] Device designers may be presented with countless options. Because design criteria often conflict, certain design choices may be far removed from convention or even unavoidable. Furthermore, comfort and effectiveness in some aspects can be highly sensitive to even slight changes in one or more parameters. 2.2.3.3 Air Circuit

[0059] An air circuit is a conduit or tube constructed and positioned so that, during use, airflow moves between two components of a respiratory therapy system (e.g., an RPT device and a patient interface). In some cases, there may be separate limbs of the air circuit for inspiration and expiration. In other cases, a single-limb air circuit is used for both inspiration and expiration. 2.2.3.4 Humidifier

[0060] Delivering airflow without humidification can lead to airway dryness. Using a humidifier with the RPT device and patient interface generates humidifying gas, minimizing nasal mucosal dryness and increasing patient airway comfort. Additionally, in cooler climates, warm air applied to the facial area within and around the patient interface is generally more comfortable than cold air. 2.2.3.5 Data Management

[0061] For clinical reasons, data may be obtained to determine whether a patient prescribed respiratory therapy is "compliant" (for example, whether the patient is using their RPT device in accordance with one or more "compliance rules"). For example, a compliance rule for CPAP therapy might require a patient to use their RPT device for at least four hours per night for at least 21 consecutive days out of a 30-day period in order to be considered compliant. To determine patient compliance, an RPT device provider (e.g., a healthcare provider) may manually collect data describing the patient's therapy using the RPT device, calculate usage rates over a given period, and compare this to the compliance rules. If the healthcare provider determines that a patient has used their RPT device in accordance with the compliance rules, they may notify third parties that the patient is compliant.

[0062] In patient therapy, there may be other ways in which patients benefit from the communication of therapeutic data to third parties or external systems.

[0063] Existing processes for communicating and managing such data can be costly, time-consuming, and prone to errors. 2.2.3.6 Ventilation Technology

[0064] Some forms of treatment systems may include vents to expel exhaled carbon dioxide. These vents may allow gas to flow from the internal space of the patient interface (e.g., the plenum chamber) to the outside of the patient interface (e.g., the surroundings).

[0065] This ventilation section may include an orifice, through which gas can flow when a mask is used. Many such ventilation sections are noisy. In other cases, they may become blocked during use, resulting in insufficient airflow. In some ventilation sections, noise or concentrated airflow may disrupt the sleep of 1100 people sharing a bed with 1000 patients.

[0066] ResMed Limited has developed several improved mask ventilation technologies. See International Patent Application Publication No. 1998 / 034665, International Patent Application Publication No. 2000 / 078381, U.S. Patent No. 6,581,594, U.S. Patent Application Publication No. 2009 / 0050156, and U.S. Patent Application Publication No. 2009 / 0044808.

[0067] [Table 2]

[0068] (*Only one sample was measured in CPAP mode at 10 cmH2O using the test method specified in ISO 3744.)

[0069] The sound pressure values ​​of various objects are listed below:

[0070] [Table 3]

[0071] 2.2.4 Screening, diagnostic, and monitoring systems Polysomnography (PSG) is a conventional system for the diagnosis and monitoring of cardiopulmonary disorders, and typically requires specialized clinical staff for system application. In PSG, typically 15-20 tactile sensors are placed on the patient to record various bodily signals such as electroencephalography (EEG), electrocardiogram (ECG), electrooculography (EOG), and electromyography (EMG). PSG for sleep-disordered breathing requires the patient to be observed over two nights in a clinic; the first night is purely for diagnosis, and the second night is for treatment parameter titration by the clinician. Therefore, PSG is costly and inconvenient. Screening / diagnosis / monitoring of sleep-disordered breathing is particularly unsuitable for home use.

[0072] Generally, screening and diagnosis involve identifying a disease based on its signs and symptoms. Screening typically yields true / false results indicating whether a patient's SDB warrants further investigation, while diagnosis often provides clinically actionable information. Screening and diagnosis tend to be one-time procedures, whereas monitoring the course of a disease can continue indefinitely. Some screening / diagnostic systems are designed solely for screening / diagnosis, while others can also be used for monitoring.

[0073] Clinical professionals can appropriately screen, diagnose, or monitor patients based on visual observation of PSG signals. However, there are situations where clinical professionals are unavailable or cannot be paid. Clinical professionals may have differing opinions regarding a patient's condition. Furthermore, a particular clinical professional may apply different criteria each time. 2.2.5 Immersive Technology

[0074] Immersive technology refers to technologies that create a sense of surroundings and replicate or extend the physical environment through a digital or virtual environment, thereby generating a feeling of immersion.

[0075] In particular, immersive technologies provide users with a visual sense of immersion and create virtual objects and virtual environments. Immersive technologies can also provide immersion in at least one of the other five senses. 2.2.6 Virtual Reality

[0076] Virtual reality (VR) is a computer-generated three-dimensional image or environment presented to a user. In other words, the environment may be entirely virtual. Specifically, the user observes an electronic screen to view virtual images or computer-generated images within a virtual environment. Because the created environment is entirely virtual, the user may have their interaction with the physical environment blocked or hindered (for example, they may not be able to hear or see the sounds of physical objects in the physical environment they are currently in).

[0077] The electronic screen may be supported in the user's line of sight (for example, mounted on the user's head). While observing the electronic screen, the visual feedback output by the screen and observed by the user may generate a virtual environment intended to simulate a real environment. For example, the user may be able to pivot their head or entire body to look around (e.g., 360°) or interact with virtual objects that the user can observe through the electronic screen. This may provide the user with an immersive experience in which the virtual environment stimulates at least one of the user's five senses, replacing the corresponding stimuli of the physical environment while the user is using the VR device. Typically, the stimuli relate to at least the user's vision (i.e., because they are looking at the electronic screen), but other senses may also be involved. Since the electronic screen is usually mounted on the user's head and may be located near the user's eyes, the user can easily observe the virtual environment.

[0078] VR devices may generate other forms of feedback in addition to, or separate from, visual feedback. For example, a VR device may include or be connected to speakers to provide auditory feedback. A VR device may also include haptic feedback (e.g., in the form of haptic responses) that can correspond to visual and / or auditory feedback. This can create a more immersive virtual environment as the user receives stimuli that correspond to two or more of the user's senses.

[0079] While using a VR device, users may want to restrict their exposure to ambient stimuli. For example, a user might want to avoid seeing or hearing their surroundings in order to better process stimuli from the VR device within the virtual environment. Therefore, a VR device may restrict or prevent the user's eyes from receiving ambient light. In some examples, this may be done by providing a shield to the user's face. In some examples, the shield may be placed near the user's face (e.g., in contact or in close proximity), but not in close contact with the user's face. In either example, since ambient light does not need to reach the user's eyes, the only light the user can observe is the light from the electronic screen.

[0080] In other examples, the VR device may limit and / or prevent the user's ears from hearing ambient noise. In some examples, this may be done by providing the user with headphones (e.g., noise-canceling headphones) that may output sound from the VR device or limit the user from hearing noise from the physical environment. In some examples, the VR device may output sound at a volume sufficient to prevent the user from hearing ambient noise.

[0081] In either example, the user does not necessarily want to be overstimulated (for example, by both the physical and virtual environments). Therefore, blocking and / or limiting ambient noise that distracts the user helps them concentrate on the virtual environment without being distracted by ambient sounds.

[0082] The following describes various types of VR devices. Typically, a single VR device may encompass at least two different classifications. For example, VR devices may be classified by portability or by how the display unit is coupled with the rest of the interface. These classifications may be independent, so that a classification within one group (e.g., unit portability) is not predetermined to belong to another group. Additional categories for classifying VR devices may also exist, but these are not explicitly listed below. 2.2.6.1 Portability 2.2.6.1.1 Fixed Unit

[0083] In some forms, VR devices may be used in combination with other devices such as computers or video game consoles. These types of VR devices may be fixed in place because they cannot be used without a computer or video game console, thus limiting their location of use (for example, the location of the computer or video game console).

[0084] Since VR devices can be used in conjunction with computers or video game consoles, they may be connected to the computer or video game console. For example, a power cord may connect the two systems together. This may further "fix" the position of the VR device, as the user wearing the VR device cannot move beyond the length of the power cord from the computer or video game console. In other examples, the VR device may be connected wirelessly (e.g., via Bluetooth, Wi-Fi, etc.) and may be fixed relatively by the strength of the wireless signal.

[0085] Control functions may be provided to the VR device by connecting it to a computer or video game console. The controls may communicate (i.e., via a wired connector or wirelessly) to assist in operating the VR device. In the case of a fixed-unit VR device, these controls may be necessary to operate the display screen, and the VR device may not be operable without being connected to a computer or video game console.

[0086] In some configurations, a computer or video game console may power the VR device, eliminating the need for the user to support the battery on their head. This can make the VR device more comfortable to wear, as the user does not have to support the weight of the battery.

[0087] Users can also receive output from a computer or video game console via a VR device, rather than from a television or monitor. This can provide users with a more immersive experience while using the computer or video game console (for example, playing a video game). In other words, the display output of a VR device may be substantially the same as the output from a computer monitor or television. Some of the controls and / or sensors necessary to output these images may be housed in the computer or video game console, which may further reduce the weight that the user needs to support with their body.

[0088] In some configurations, motion sensors may be located away from the VR device and connected to a computer or video game console. For example, at least one camera may face the user to track the user's head movements. Processing of data recorded by the camera(s) may be performed by the computer or video game console before it is sent to the VR device. This may contribute to making the VR device lighter, but it may further restrict where the VR device can be used. In other words, the VR device must be within the field of view of the camera(s). 2.2.6.1.2 Portable Unit

[0089] In some forms, VR devices may be self-contained units containing power and sensors, eliminating the need to connect them to a computer or video game console. This allows users greater freedom of use and mobility. For example, users are not limited to using VR devices near a computer or video game console, but can use them outdoors or in other environments without a computer or television.

[0090] Because VR devices are not connected to the computer or video game console being used, they need to support all the necessary electronic components. These include batteries, sensors, and processors. These components add weight to the VR device, which the user must support with their body. Proper weight distribution may be necessary to prevent this additional weight from increasing discomfort for the user wearing the VR device.

[0091] In some configurations, the electrical components of the VR device may be housed in a single housing and positioned directly in front of the user's face during use. This configuration may be called a “brick.” In this configuration, the center of gravity of the VR device, without positioning and stabilization structures, is directly in front of the user's face. To counteract the moment caused by gravity, positioning and stabilization structures coupled to the brick configuration need to provide forces directed toward the user's face, such as those generated by the tension of the headgear straps. While brick configurations are advantageous in manufacturing (e.g., all electrical components are in close proximity) and may allow for the compatibility of positioning and stabilization structures (e.g., due to the absence of electrical connections), the forces required to maintain the position of the VR device (e.g., headgear tension) can be uncomfortable for the user. Specifically, the VR device may dig into the user's face, potentially causing irritation or scarring of the user's skin. Because the user's head experiences forces from the display housing on the face and from the headgear at the back of the head, the combination of forces may feel like it is “tightening.” This may cause the user to stop wearing the VR device.

[0092] VR and other mixed reality devices may be used in ways that involve vigorous movement of the user's head or entire body (for example, during gaming), potentially generating significant forces or moments that tend to disrupt the device's position on the user's head. Simply pressing the device firmly against the user's head to withstand such strong forces may be unacceptable, as it could be uncomfortable or quickly become uncomfortable for the user.

[0093] In some configurations, electrical components may be spaced out across the entire VR device rather than across the entire front of the user's face. For example, some electrical components (e.g., batteries) may be located in the positioning and stabilization structure, particularly in the rear contact area. In this way, the weight of the battery (or other electrical components) may generate a moment in the opposite direction to the moment generated by the rest of the VR device (e.g., the display). Therefore, the positioning and stabilization structure may only need to apply a lower clamping force, resulting in less force on the user's face (e.g., fewer marks left on the skin). However, in some existing devices, the electrical connections may make cleaning and replacing the positioning and stabilization structure more difficult. In some configurations, separating electrical components requires positioning some electrical components separately from the rest of the VR device. For example, the battery and / or processor may be electrically connected but carried separately from the rest of the VR device. Unlike the “fixed unit” described above, the battery and / or processor may be carried together with the rest of the VR device. For example, the battery and / or processor may be carried on the user’s belt or in a pocket. This may have the advantage of reducing the weight on the user’s head, but it does not provide a reaction moment. Because the total weight supported by the head is less, the tension provided by the positioning and stabilization structure may be less than in a “brick” configuration. 2.2.6.2 Display Connection 2.2.6.2.1 Integrated Display Screen

[0094] In some forms, the display screen is an integrated component of the VR device and is usually not removable from the rest of the VR device.

[0095] The display screen may be secured within the housing and protected from damage. For example, the display screen may be completely covered by the housing, reducing the likelihood of scratches. Furthermore, integrating the display screen with the rest of the VR device eliminates the possibility of losing the display screen.

[0096] In these configurations, the display screen functions purely as an immersive technology display. Most "fixed units" include an integrated display screen. "Portable units" may include an integrated display screen or a detachable display screen (described below). 2.2.6.2.2 Removable display screen

[0097] In some forms, the display screen is a separate structure that can be detached from the VR device and used separately.

[0098] In some forms, a portable electronic device (e.g., a mobile phone) may be selectively inserted into the housing of the VR device. The portable electronic device may contain most or all of the sensors and processors and may create a virtual environment through a downloadable app.

[0099] Portable electronic devices are generally lightweight and do not require positioning and stabilization structures to apply significant force to the user's head. 2.2.7 Augmented Reality

[0100] In some forms, augmented reality (AR) is a computer-generated three-dimensional image or environment presented to the user.

[0101] Similar to VR, AR differs in that a virtual environment, at least partially created by an electronic screen, is observed in combination with the user's physical environment. In other words, AR creates virtual objects and uses elements of the virtual environment to modify and / or enhance the user's physical environment. The result of AR is a composite environment containing both physical and virtual objects, and therefore both physical and virtual environments.

[0102] For example, images created by an electronic screen may be overlaid on the user's physical environment. Only a portion of the AR composite environment presented to the user is virtual. Therefore, the user may want to continue receiving ambient stimuli from the physical environment while using the AR device (for example, to continuously observe the physical or non-virtual components of the composite environment).

[0103] Because AR can be used in the user's physical environment, AR devices cannot be electrically or otherwise connected to a computer or video game console. Instead, AR devices may contain batteries or other power sources. This allows users to have maximum freedom of movement and explore various physical environments while using the AR device.

[0104] This crucial difference between VR and AR can lead to variations in the type of wearable electronic screen used. As mentioned earlier, users of VR devices may want to block out ambient light, so the electronic screen housing may be opaque to limit or prevent ambient light from reaching the user. Users of AR devices, however, may want to see the virtual environment fused with the real environment. While the electronic screen of an AR device is similarly supported in front of the user's eyes, the screen of an AR device may be transparent or translucent, and the screen may not be supported by an opaque housing (or the opaque material may not substantially obstruct the user's line of sight). This allows the user to continue to receive ambient stimuli if the virtual environment is present simultaneously. However, some VR devices that do not include a transparent screen that allows the user to observe their surroundings in the real world may be configured for AR by capturing real-time video of the user's surroundings in the real world from the user's point of view (e.g., using a camera on the display housing) and displaying it on the display screen.

[0105] Furthermore, (for example, because AR users can observe their physical environment or are not tied to a computer or video game console) people using AR devices may be more mobile than people using VR devices. Therefore, people using AR devices may want to wear the device for extended periods while moving around (for example, walking, running, cycling, etc.). Including components such as batteries in AR devices may cause discomfort to the user's head and neck, potentially discouraging users from wearing AR devices for long periods. 2.2.8 Mixed Reality

[0106] Mixed reality (MR) is similar to augmented reality (AR), but MR devices allow users to interact with virtual objects and environments in more ways than AR devices, potentially leading to a more immersive experience. MR's virtual reality can also be superimposed on or merged with the user's physical environment. However, unlike AR, users may be able to interact with the virtual environment in a similar way to what happens in virtual reality (VR). In other words, while AR only presents computer-generated images in the physical environment, MR presents the user with the same or similar computer-generated images, allowing interaction with the images in the physical environment (such as "grabbing" a virtually generated object with your hands). Thus, the virtual environment merges even more with the physical environment, and the combined environment can better replicate the real environment. 2.2.9 Head-mounted display interface

[0107] Head-mounted display interfaces enable users to have immersive experiences in virtual environments and have a wide range of applications in fields such as communications, training, medical and surgical procedures, engineering, and video games.

[0108] Head-mounted display interfaces can offer different levels of immersion. For example, some head-mounted display interfaces can provide users with complete immersion. Virtual reality (VR) is an example of complete immersion. Head-mounted display interfaces can also offer partial immersion, which is aligned with the use of augmented reality (AR) devices.

[0109] A VR head-mounted display interface is typically provided as a system including a display unit configured to be held in an operable position in front of the user's face. The display unit typically includes a housing that contains the display and a user interface structure constructed and positioned to face the user's face. The user interface structure may extend around the display and, in conjunction with the housing, define the viewing opening of the display. The user interface structure may include cushions that engage with the face and enhance user comfort, and / or a light-shielding structure to block ambient light from the display. The head-mounted display system further includes positioning and stabilization structures that are positioned on the user's head to hold the display unit in place.

[0110] Other head-mounted display interfaces may not provide complete immersion. In other words, users can experience elements of the physical environment as well as the virtual environment. Examples of experiences that do not provide complete immersion include augmented reality (AR) and mixed reality (MR).

[0111] AR and / or MR head-mounted display interfaces are also typically provided as a system that includes a display unit configured to be held in an interactive position in front of the user's face. Similarly, the display unit typically includes a housing containing the display and a user interface structure built and positioned to face the user's face. The head-mounted display system of an AR and / or MR head-mounted display is similar to VR in that it further includes a positioning and stabilization structure that is located on the user's head to hold the display unit in place. However, AR and MR head-mounted displays do not include a cushion to completely block out ambient light from the display. This is because these experiences, which do not provide complete immersion, require elements of the physical environment. Instead, augmented and / or hybrid head-mounted displays allow the user to see a combination of the physical and virtual environments.

[0112] In all types of immersive technologies, it is crucial that the interface of the head-mounted display is comfortable so that users can wear it for extended periods. Furthermore, it is important that the display can provide images that change in accordance with changes in the user's head position and orientation in order to create partially or fully virtual environments that are similar to or replicate the physical environment perfectly. 2.2.9.1 Interface Structure

[0113] The head-mounted display may include a user interface structure. Since the seal-forming structure comes into direct contact with the patient's face, its shape and configuration directly affect the effectiveness and comfort of the patient interface.

[0114] Designing user interface structures presents many challenges. The face has a complex three-dimensional shape. The size and shape of the nose and head vary greatly from person to person. Because the head contains bone, cartilage, and soft tissue, different areas of the face respond differently to mechanical forces.

[0115] One type of interface structure extends around the display unit and is intended to seal against the user's face when force is applied to the user interface while the interface structure is facing and engaged with the user's face. The interface structure may include a polyurethane (PU) pad. In this type of interface structure, a gap may exist between the interface structure and the surface, and additional force may be required to press the display unit against the surface to achieve the desired contact.

[0116] In areas where the user interface is not involved at all, a gap can form between the facial interface and the user's face, potentially allowing undesirable light pollution to enter the display unit (for example, especially when using virtual reality). Light pollution and "light leaks" can reduce the effectiveness and enjoyment of the user's overall immersion. In addition, conventional systems can be difficult to adapt to various head sizes. Furthermore, the display unit and associated stabilization structures are often relatively heavy and can be difficult to clean, which can further limit the comfort and usability of the system.

[0117] Another type of interface structure incorporates a flap seal made of thin material positioned around part of the display unit, providing a sealing effect against the user's face. As with previous styles of interface structures, if the match between the surface and the interface structure is not good, additional force may be required to achieve the seal, or light may leak into the display unit during use. Furthermore, if the shape of the interface structure does not match the shape of the user, it may crease or distort during use, resulting in undesirable light transmission.

[0118] The user interface may be partially characterized according to the design intent of where the interface structure engages with the face during use. Some interface structures may be restricted to engaging with areas of the user's face that protrude beyond the curvature arc of the interface structure's face engagement surface. These areas may typically include the user's forehead and cheekbones. This may cause discomfort to the user at localized stress points. Other facial areas may not engage at all or only negligibly with the interface structure, and therefore may be insufficient to increase the distance traveled by the clamping pressure. These areas may typically include the sides of the user's face or the area adjacent to and surrounding the user's nose. When there is a mismatch between the shape of the user's face and the interface structure, it is advantageous that the interface structure or related components are adaptable so that appropriate contact or other relationship is formed. 2.2.9.2 Positioning and Stabilization

[0119] To hold the display unit in the correct, operable position, the head-mounted display system further includes positioning and stabilization structures positioned on the user's head. These structures may also serve to provide counteracting forces against gravity for the head-mounted display and / or interface structure. Traditionally, these structures have been formed from expandable, rigid structures typically applied to the head under tension to hold the display unit in an operable position. Such systems tend to exert constricting pressure on the user's face, potentially causing discomfort at localized stress points. Furthermore, conventional systems can be difficult to adjust to accommodate a wide range of application head sizes. In addition, the display unit and associated stabilization structures are often heavy and difficult to clean, further limiting the comfort and usability of the system.

[0120] Other specific head-mounted display systems may not be functionally suitable for this field. For example, positioning and stabilization structures designed for decorative or visual aesthetics may not have the structural ability to maintain appropriate pressure around the face. For instance, excessive clamping pressure may cause discomfort to the user. Alternatively, insufficient clamping pressure on the user's face may prevent the display from effectively blocking ambient light.

[0121] Other specific head-mounted display systems may be uncomfortable or impractical with current technology, for example, when the system is used for extended periods.

[0122] As a result of these challenges, some head-mounted displays have problems such as being visually distracting, aesthetically unappealing, expensive, having a poor fit, being difficult to use, and being uncomfortable, especially when worn for extended periods or when the user is unfamiliar with the system. Inappropriate sizing of the positioning and stabilization structures can reduce comfort and shorten the lifespan of the device.

[0123] Therefore, the interface portion of the user interface used for a fully immersive virtual environment experience is affected by forces that correspond to the user's movements during the experience. 2.2.9.3 Materials

[0124] Materials used in head-mounted display assemblies include high-density foam for contact surfaces of interface structures, rigid shells for housings, and positioning and stabilizing structures formed from rigid plastic clamp structures. These materials have various drawbacks, such as preventing skin from breathing, lacking flexibility, being difficult to clean, and being prone to bacterial adhesion. As a result, products made from such materials can become uncomfortable with prolonged wear, cause skin irritation in some individuals, and limit the range of applications for the product. [Overview of the project] [Means for solving the problem]

[0125] This technology relates to providing medical devices used in the screening, diagnosis, monitoring, improvement, treatment, or prevention of respiratory diseases, wherein these medical devices have one or more of the following advantages: improved comfort, cost, effectiveness, ease of use, and manufacturability.

[0126] A first aspect of this technology relates to a device used for screening, diagnosing, monitoring, improving, treating or preventing respiratory disorders.

[0127] Another aspect of this technology relates to a method used in screening, diagnosing, monitoring, improving, treating or preventing respiratory disorders.

[0128] One aspect of several forms of this technology is to provide a method and / or apparatus for improving respiratory therapy compliance in patients.

[0129] One embodiment of this technology includes a patient interface that includes a flow generator for providing a pressurized airflow to the patient.

[0130] Another aspect of one embodiment of this technology is a flow generator casing connected to a patient interface cushion, the flow generator casing housing a blower for supplying pressurized air to the cushion.

[0131] Another aspect of one form of this technology is a power supply that is detachably connected to the patient interface in order to supply electrical energy to the patient interface.

[0132] In one configuration, the power source is a rechargeable battery directly connected to the patient interface.

[0133] Another aspect of one form of this technology is a patient interface including a cushion and a blower in a blower housing directly connected to the cushion. The patient interface also includes a power source that supplies electrical energy to the blower.

[0134] In one configuration, the blower and / or power supply are worn and supported by the user during use.

[0135] Another aspect of one embodiment of the present technology is a patient interface comprising: a plenum chamber pressurized to a therapeutic pressure; a seal-forming structure that forms a seal against the patient's face; a positioning and stabilizing structure configured to provide force to maintain the seal-forming structure in a therapeutically effective position; a blower directly connected to the plenum chamber and supplying airflow at the therapeutic pressure; and a power supply electrically connected to the RPT device, wherein the positioning and stabilizing structure is configured to support at least a portion of the weight of the RPT device.

[0136] In some forms, a) the positioning and stabilization structure may support at least a portion of the weight of the power supply; b) the power supply is a rechargeable battery; and / or c) the patient interface is detachably connected to a charger for charging the battery.

[0137] In some embodiments, a) the RPT device includes a flow generator casing having a cavity for housing a blower, b) the cavity being in fluid communication with the plenum chamber, and / or c) the flow generator casing extending around at least a portion of the plenum chamber.

[0138] In some forms, a) the RPT device includes a valve located between the blower and the plenum chamber, and / or b) the valve is a one-way valve.

[0139] Another aspect of one form of this technology is a patient interface molded or otherwise constructed together with a peripheral shape that is complementary to the shape of the intended wearer.

[0140] Another aspect of one embodiment of the present technology is a head-mounted display interface comprising: a user interface structure configured to contact the face of a user, the user interface structure including at least one first opening configured to receive at least one of the user's eyes and at least one second opening configured to receive at least one of the user's nostrils; a display unit housing connected to the user interface structure, the display unit housing including a display configured to output computer-generated images through the at least one first opening; a blower configured to output a pressurized airflow through the at least one second opening; and a support structure connected to the display unit housing and / or the user interface structure, configured to maintain the user interface structure in a desired position on the user's face.

[0141] In some configurations, the blower is constructed and positioned to provide a supply of air at a positive pressure of at least 4 cmH2O relative to the surroundings.

[0142] In some forms, the head-mounted display interface further includes an audio system configured to output sound to the user.

[0143] Another aspect of the present technology relates to a patient interface for treating patients with respiratory diseases, the patient interface comprising a respiratory pressure therapy (RPT) device including an electric blower configured to produce pressurized breathable air; a seal-forming structure configured to form a seal to the patient's face, the seal-forming structure at least partially defining a plenum chamber configured to receive pressurized air; a flow generator casing at least partially surrounding the electric blower and connected to the plenum chamber, the casing including at least one air opening for receiving ambient air to be delivered to the RPT device; and a positioning and stabilizing structure configured to maintain the seal-forming structure and the blower in a therapeutically effective position.

[0144] In some forms, the patient interface may include at least one of the following:

[0145] The patient interface does not have a tube or forehead support configured to extend between the patient's eyes. The positioning and stabilization structures are connected to the casing and / or plenum chamber. The casing includes a rear case and a front case that define a cavity in which the blower is completely sealed. The casing has a curvature that is designed to enclose the patient's face. The curvature of the front case and the curvature of the rear case are complementary. The casing comprises a central section and two lateral sections, the central section housing a blower, the central section and the lateral sections providing continuous curvature, the central section of the front case being removable from the lateral sections, or the central section of the front case being integrally formed with the lateral sections of the front case. The front case is removably attached to the rear case to expose the blower in the cavity and one or more electrical components in the cavity. The one or more electrical components include a pressure sensor, The rear case is covered with at least some fiber, The blower has a substantially cylindrical shape and is positioned laterally within the cavity in front of the rear case. The longitudinal axis of the blower extends perpendicularly to the inlet of the casing that connects to the plenum chamber. The suspension supports the blower within the cavity, The suspension has at least a first opening that allows ambient airflow to the blower and a second opening that receives the pressurized air, The manifold is located inside the cavity and is configured to guide pressurized air from the blower towards the plenum chamber. The manifold guides the pressurized air back from one direction to the other. The suspension includes an opening that guides the pressurized air generated by the blower to the manifold. The rear case includes a central groove or recess for receiving and supporting the blower, The aforementioned central groove or recess extends laterally and has a semi-cylindrical shape. The plenum chamber includes a front surface having a recessed portion that receives the convex outer portion of the casing or rear case that houses the blower. The casing or rear case includes an inlet tube located above a convex outer portion of the casing or rear case, the plenum chamber includes an inlet opening located above a recess in the plenum chamber and removablely attached to the inlet tube, and an expiratory-activated valve that directs pressurized gas from the cavity to the plenum chamber during inhalation and / or from the plenum chamber to the exhaust channel of the casing during exhalation. The valve includes a one-way duckbill valve that directs the incoming pressurized gas into the plenum chamber. The EAV includes a membrane that moves during exhalation to guide the exhaled air along the outside of the duckbill valve and out to the surroundings through the gas exhaust vent, so that the exhaled air passes through the exhaust channel during use. The exhaust channel guides the exhaled gas to a gas exhaust vent having one or more holes connected to the surroundings. The duckbill valve is located within the inlet of the casing connected to the plenum chamber. The blower further includes at least one muffler located at at least one end of the blower, At least one gas exhaust vent is provided to exhaust exhaled gases into the surroundings. The gas exhaust vent is provided in part of the front case and / or rear case and / or the seal forming portion. The blower includes at least one pair of impellers coupled to a common shaft and arranged in parallel, The impeller is a double-sided impeller, The blower further includes an elastomer bearing configured to limit vibrations, The seal-forming portion includes a pillow mask, a full-face mask, or a nose mask. The seal-forming portion includes a first portion that surrounds the patient's mouth and a second portion that seals the underside of the patient's nose. The second portion includes a pair of openings for alignment with the patient's nostrils, The seal-forming portion does not extend beyond the nasal bridge of the patient. The electrical connector is for connecting to a power cord to supply power to the blower using a power source, and / or the battery is for supplying power to the blower using a power source. The system further includes a battery connected to the strap of the positioning and stabilization structure, and a conductor formed as part of the strap and connected to the blower, The positioning and stabilization structure further includes a strap or power cord connected to the casing, the power cord being configured to draw power from an AC outlet or a remote battery.

[0146] This technology may also include providing an interface structure used to support, buffer, stabilize, position, and / or seal a head-mounted display that is in a position opposite to the user's face.

[0147] Another aspect relates to a device used to support, cushion, stabilize, position, and / or seal a head-mounted display that is in a position opposite to the user's face.

[0148] Another aspect relates to a method used to support, cushion, stabilize, position, and / or seal a head-mounted display that is in a position opposite to the user's face.

[0149] One aspect of this technology relates to a patient interface that combines features of AR / VR and respiratory therapy.

[0150] One embodiment of the present technology relates to a patient interface for treating patients with respiratory diseases, comprising: an RPT device including an electric blower configured to generate pressurized breathable air; a user interface structure configured to engage with the face of a patient, the user interface structure forming at least partially a plenum chamber configured to receive pressurized breathable air; a head-mounted interface configured to substantially cover the eyes of a patient; a flow generator casing at least partially surrounding the head-mounted interface and the electric blower, and connected to the plenum chamber, the flow generator casing including at least one air opening for receiving ambient air to be delivered to the RPT device; and a positioning and stabilizing structure configured to maintain the user interface structure in a therapeutically effective position.

[0151] In one example, the head-mounted interface is a form of head-mounted display interface configured to generate computer-generated images for a patient. In an alternative example, the head-mounted interface may not include either a display or a screen, and may not generate any computer-generated images.

[0152] In one example, the user interface structure includes a stability cushion component and a treatment cushion component that is separate from and different from the stability cushion component.

[0153] In one example, the stabilizing cushion component is configured to extend primarily around the patient's eyes and form a viewing opening for a head-mounted interface.

[0154] In one example, the treatment cushion component is configured to form a plenum chamber and create a seal with the patient's nose and / or mouth.

[0155] In one example, the stabilization cushion component is configured to be detachably and interchangeably connected to the flow generator casing, and the treatment cushion component is configured to be detachably and interchangeably connected to the stabilization cushion component and / or the flow generator casing.

[0156] In one example, the stabilizing cushion component is configured to engage with the patient's face and provide a substantially complete seal around the patient's eyes.

[0157] In one example, the stability cushion component includes a chassis and a cushion configured to engage with the patient's face, the chassis being configured and positioned to repeatedly engage with and disengage from the flow generator casing.

[0158] In one example, the chassis is relatively harder than the cushion.

[0159] In one example, the cushion includes a face-contact portion configured to engage with the patient's face, and a non-face-contact portion configured to connect the cushion to the chassis.

[0160] In one example, the face contact portion includes a foam cushion, which includes a face engagement surface configured to contact the patient's face around the user's eyes.

[0161] In one example, the face contact portion includes a silicone film that includes a face engagement surface configured to contact the patient's face around the user's eyes.

[0162] In one example, the non-face contact portion includes a side wall provided on the chassis and a shelf-like portion configured to protrude away from the side wall in a cantilever manner, and the non-face contact portion is configured to have an elastic spring-like support provided on the face contact portion.

[0163] In one example, the chassis of the stability cushion component provides an interface with the treatment cushion component.

[0164] In one example, the interface includes a manifold configured to form an airflow path that delivers pressurized, breathable air from a blower to a therapeutic cushion component.

[0165] In one example, the treatment cushion component is configured to be detachably and interchangeably connected to the flow generator casing.

[0166] In one example, the treatment cushion component includes a front portion, as well as a cushion configured to form a seal with the patient's nose and / or mouth.

[0167] In one example, the front portion is relatively harder than the cushion.

[0168] In one example, the cushion is a nasal cushion comprising a silicone membrane configured to form a seal with the patient's nose.

[0169] For example, the stability cushion component is offered in one size and / or type, while the treatment cushion component is offered in multiple sizes and / or types.

[0170] In one example, the patient interface further includes a manifold configured to form an airflow path that delivers pressurized, breathable air from a blower to a treatment cushion component.

[0171] In one example, the manifold and the treatment cushion component work together to house an expiratory-actuated valve (EAV) that directs pressurized breathable air from the blower to the treatment cushion component during inspiration and pressurized breathable air from the treatment cushion component to the exhaust channel during expiration.

[0172] In one example, the blower includes at least one pair of impellers coupled to a common shaft and arranged in parallel.

[0173] In one example, the patient interface further includes a pair of batteries supported by a flow generator casing on each side of the blower.

[0174] In one example, the positioning and stabilization structure is connected to at least a portion of the flow generator casing.

[0175] One embodiment of this technology relates to a user interface structure for a patient interface configured to treat a patient with a respiratory disease, wherein the user interface structure includes a stability cushion component and a treatment cushion component separate from and distinct from the stability cushion component.

[0176] In one example, the stabilizing cushion component is configured to extend primarily around the patient's eyes.

[0177] In one example, the treatment cushion component is configured to form a plenum chamber and create a seal with the patient's nose and / or mouth.

[0178] One embodiment of this technology relates to a stabilizing cushion component for a patient interface configured to treat a patient with a respiratory disease, wherein the stabilizing cushion component is configured to extend primarily around the patient's eyes.

[0179] One embodiment of the present technology relates to a therapeutic cushion component for a patient interface configured to treat a patient with a respiratory disease, wherein the therapeutic cushion component is configured to form a plenum chamber and to form a seal with the patient's nose and / or mouth.

[0180] One embodiment of this technology relates to a full-face patient interface for respiratory therapy, which includes a seal-forming structure having a two-part cushion structure.

[0181] In one example, the seal-forming structure includes a nasal cushion component and a mouth cushion component that is separate from and distinct from the nasal cushion component.

[0182] In one example, the nose cushion component is configured to be detachably and interchangeably connected to the casing, and the mouth cushion component is configured to be detachably and interchangeably connected to the casing independently of the nose cushion component.

[0183] One embodiment of this technology is a method for manufacturing an apparatus.

[0184] One particular aspect of this technology is a medical device that is easy to use for, for example, a person who has not received medical training, is not very dexterous, lacks insight, or has limited experience using this type of medical device.

[0185] One embodiment of this technology is a portable RPT device that can be carried by the user, for example, at the user's home.

[0186] One embodiment of this technology is a patient interface that can be cleaned at the patient's home with, for example, soapy water, without the need for special cleaning equipment. Another embodiment of this technology is a humidifier tank that can be cleaned at the patient's home with, for example, soapy water, without the need for special cleaning equipment.

[0187] The methods, systems, devices, and apparatus described may be implemented to improve the functionality of processors such as dedicated computers, respiratory monitors, and / or respiratory therapy devices. Furthermore, the methods, systems, devices, and apparatus described above can provide improvements in the field of automated management, monitoring, and / or treatment of respiratory conditions, including sleep-disordered breathing, for example.

[0188] Of course, some embodiments may form subordinate embodiments of the Technology. Furthermore, sub-embodiments and / or various embodiments may be combined in various ways to constitute additional embodiments or sub-embodiments of the Technology.

[0189] Other features of this technology will become apparent by considering the information contained in the embodiments, abstract, drawings, and claims for carrying out the invention described below.

[0190] This technology is illustrated in the attached drawings as a non-limiting embodiment. In the drawings, similar reference numerals refer to similar elements, including the following: 4.1 Respiratory Therapy System [Brief explanation of the drawing]

[0191] [Figure 1A] The system includes patient 1000 wearing patient interface 3000. This system takes the form of a nasal pillow and receives positive-pressure air supplied from RPT device 4000. The air from RPT device 4000 is humidified in humidifier 5000 and delivered to patient 1000 through air circuit 4170. A bedmate 1100 is also illustrated. The patient is sleeping in a supine position. [Figure 1B] The system includes a patient 1000 wearing a patient interface 3000 in the form of a nasal mask that receives positive-pressure air supplied from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. [Figure 1C]The system includes a patient 1000 wearing a patient interface 3000 in the form of a full-face mask that receives positive-pressure air supplied from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. The patient is sleeping in a lateral sleeping position. 4.2 Anatomy of the Respiratory System and Face [Figure 2A] This diagram outlines the human respiratory system, including the nasal cavity and oral cavity, larynx, vocal cords, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm. [Figure 2B] This diagram shows the human upper respiratory tract, including the nasal cavity, nasal bone, lateral nasal cartilage, greater alar cartilage, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cord folds, esophagus, and trachea. [Figure 2C] This is a frontal view of the face including several features of surface anatomical structures, including the upper lip, upper lip robe, lower lip robe, lower lip, width of the mouth, medial canthus, nasal wings, nasolabial folds, and cheirion. The superior, inferior, radially medial, and radially lateral directions are also indicated. [Figure 2D] This is a lateral view of the head, including several features of surface anatomical structures, such as the glabella, therion, nasal tip, subnasal point, upper lip, lower lip, supramenton, nasal ridge, ala apex, superior and inferior base of the ear. The superior and inferior, and anterior and posterior directions are also indicated. [Figure 2E] This is a further lateral view of the head. The approximate positions of the Frankfort horizontal and nasolabial angles are indicated. The coronal plane is also shown. [Figure 2F] This is a pedicle view of the nose, including several features such as the nasolabial folds, lower lip, upper lip red, nostrils, subnasal point, columella, nasal tip, main axis of the nostrils, and median sagittal plane. [Figure 2G] This is a lateral view of the surface features of the nose. [Figure 2H] This shows the subcutaneous structure of the nose, including the lateral nasal cartilages, nasal septal cartilages, greater alar cartilages, lesser alar cartilages, nasal sesamoid cartilages, nasal bone, epidermis, adipose tissue, the frontal process of the maxilla, and fibrous adipose tissue. [Figure 2I]This shows a mid-nasal incision located approximately a few millimeters from the midline sagittal plane, particularly the medial crura of the nasal septum cartilage and the greater alar cartilage. [Figure 2J] This shows a frontal view of the skull, including the frontal bone, nasal bone, and zygomatic bone. The nasal conchae are illustrated together with the maxilla and mandible. [Figure 2K] A lateral view of the skull, the contour of the head surface, and several muscles are shown. The following bones are illustrated: frontal bone, sphenoid bone, nasal bone, zygomatic bone, maxilla, mandible, parietal bone, temporal bone, and occipital bone. The mental protuberance is shown. The following muscles are illustrated: digastric muscle, masseter muscle, sternocleidomastoid muscle, and trapezius muscle. [Figure 2L] This shows a frontal and lateral view of the nose. [Figure 2M] Another lateral view of the face is shown, with several surface anatomical features identified, including the skull, sphenoid bone, nasal bridge, lateral and medial buccal regions, zygomatic arch, and nasal ala apex. [Figure 2N] A lateral view of the face is shown, with several surface anatomical features identified, including the skull, sphenoid bone, nasal bridge, lateral and medial buccal regions, zygomatic arch, and nasal ala. 4.3 Patient Interface [Figure 3A] This shows a patient interface in the form of a nasal mask, which is one embodiment of this technology. [Figure 3B] This is a schematic cross-sectional view of the structure cut at a single point. The outward normal at this point is shown. The curvature at this point has a positive sign and is relatively large compared to the magnitude of curvature shown in 3C. [Figure 3C] This is a schematic cross-sectional view of the structure cut at a single point. The outward normal at this point is shown. The curvature at this point has a positive sign and is relatively small compared to the magnitude of curvature shown in Figure 3B. [Figure 3D] This is a schematic cross-sectional view of the structure cut at a single point. The outward normal at this point is shown. The curvature value at this point is zero. [Figure 3E]This is a schematic cross-sectional view of the structure cut at a single point. The outward normal at this point is shown. The curvature at this point has a negative sign and is relatively small compared to the magnitude of curvature shown in Figure 3F. [Figure 3F] This is a schematic cross-sectional view of the structure cut at a single point. The outward normal at this point is shown. The curvature at this point has a negative sign and is relatively large compared to the curvature shown in Figure 3E. [Figure 3G] The mask cushion, including two pillows, is shown. The outer surface of the cushion is shown. The edges of the surface are shown. The dome and saddle regions are illustrated. [Figure 3H] A mask cushion is shown. The outer surface of the cushion is shown. The edges of the surface are shown. The path on the surface between point A and point B is illustrated. The straight-line distance between A and B is illustrated. Two saddle regions and a dome region are illustrated. [Figure 3I] The surface of the structure is shown, and one-dimensional holes are present within this surface. The planar curves in the illustration form the boundaries of the one-dimensional holes. [Figure 3J] This is a cross-sectional view through the structure in Figure 3I. The illustrated surface defines the two-dimensional hole in the structure in Figure 3I. [Figure 3K] Figure 3I is a perspective view of the structure including two-dimensional and one-dimensional holes. The surfaces that define the two-dimensional holes in the structure of Figure 3I are also shown. [Figure 3L] This shows a mask with an inflatable bladder that acts as a cushion. [Figure 3M] Figure 3L is a cross-sectional view of the mask, showing the inner surface of the bladder. The inner surface defines the two-dimensional holes within the mask. [Figure 3N] Figure 3L shows a further cross-section through the mask. The inner surface is also illustrated. [Figure 3O] This demonstrates the left-hand rule. [Figure 3P] I will demonstrate the right-hand rule. [Figure 3Q] This shows the left ear, including the left helix. [Figure 3R] Shows the right ear, including the right helix. [Figure 3S] Show the helix of the right hand. [Figure 3T] This is a diagram of a mask that includes a sign of the twist of the spatial curve defined by the edges of the sealing membrane in different regions of the mask. [Figure 3U] This is a diagram of the plenum chamber 3200, showing the sagittal plane and the central contact surface. [Figure 3V] Figure 3U is a rear view of the plenum chamber. The directions in the figure are perpendicular to the central contact surface. In Figure 3V, the sagittal plane divides the plenum chamber into left-hand and right-hand sides. [Figure 3W] Figure 3V is a cross-sectional view through the plenum chamber, taken in the sagittal plane shown in Figure 3V. The "central contact" surface is illustrated. The central contact surface is perpendicular to the sagittal plane. The orientation of the central contact surface corresponds to the orientation of tendon 3210. Tendon 3210 rests on the sagittal plane and contacts only the cushion of the plenum chamber at two points on the sagittal plane (i.e., upper point 3220 and lower point 3230). Depending on the geometry of the cushion in this region, the central contact surface may contact both the upper and lower points. [Figure 3X] Figure 3U shows the plenum chamber 3200 in the use position on the face. The sagittal plane of the plenum chamber 3200 generally coincides with the midline sagittal plane of the face when the plenum chamber is in the use position. The central contact surface generally corresponds to the “face plane” when the plenum chamber is in the use position. In Figure 3X, the plenum chamber 3200 is part of a nasal mask, with the upper point 3220 located approximately on the serion and the lower point 3230 located on the upper lip. 4.4 RPT Device [Figure 4A] This figure shows an RPT device based on one embodiment of this technology. [Figure 4B]This is a schematic diagram of the pneumatic path of an RPT device according to one embodiment of this technology. The upstream and downstream directions are indicated with reference to the blower and patient interface. Regardless of the actual flow direction at any particular moment, the blower is defined as being upstream of the patient interface, and the patient interface is defined as being downstream of the blower. Items in the pneumatic path between the blower and the patient interface are located downstream of the blower and upstream of the patient interface. [Figure 4C] This is a schematic diagram of the electrical components of an RPT device based on one embodiment of this technology. [Figure 4D] This is a schematic diagram of an algorithm implemented in an RPT device using one form of this technology. [Figure 4E] This flowchart illustrates a method implemented by the treatment engine module shown in Figure 4D, which is one form of this technology. 4.5 Humidifier [Figure 5A] An isometric view of a humidifier based on one embodiment of this technology is shown. [Figure 5B] This shows an isometric view of a humidifier according to one embodiment of this technology, and the humidifier water tank 5110 removed from the humidifier water tank dock 5130. 4.6 Respiratory waveform [Figure 6] This shows a typical respiratory waveform model of a human during sleep. 4.7 Interface with motor [Figure 7] A perspective view of the first version of the full-face patient interface is shown. [Figure 8] Figure 7 shows a perspective view of the full-face patient interface connected to the power cord. [Figure 9] Figure 7 shows a perspective view of the full-face patient interface with alternative positioning and stabilization structures. [Figure 10] Figure 7 shows a perspective view of the full-face patient interface connected to the battery. [Figure 11] Figure 10 shows a front view of the full-face patient interface and battery. [Figure 12]Figure 10 shows a side view of the full-face patient interface and battery. [Figure 13] A perspective view of the second version of the full-face patient interface connected to the power cord is shown. [Figure 14] Figure 13 shows a perspective view of the full-face patient interface connected to the battery. [Figure 15] Figure 14 shows a front view of the full-face patient interface and battery. [Figure 16] Figure 14 shows a side view of the full-face patient interface and battery. [Figure 17] A perspective view of the first version of the nasal patient interface connected to the power cord is shown. [Figure 18] Figure 17 shows a perspective view of the nasal patient interface connected to the battery. [Figure 19] Figure 18 shows a front view of the nasal patient interface and battery. [Figure 20] A perspective view of the second version of the nasal patient interface connected to the power cord is shown. [Figure 21] Figure 20 shows a perspective view of the nasal patient interface connected to the battery. [Figure 22] Figure 21 shows a front view of the nasal patient interface and battery. [Figure 23] This shows a perspective view of the battery connected to the power cord. [Figure 24] Figure 10 shows a front view of the full-face patient interface and battery connected to the charger. [Figure 25] Figure 24 shows a side view of the full-face patient interface and charger. [Figure 26] Figure 7 shows a perspective view of a case for storing the patient interface. [Figure 27] This is a top view of a full-face patient interface with a transparent outer casing for viewing internal elements. [Figure 28]Figure 27 is a front view of the full-face patient interface. [Figure 29] Figure 28 is a cross-sectional view of the full-face patient interface, showing the components of the RPT device included within the patient interface. [Figure 30] Figure 29 is a cross-sectional view of the full-face patient interface, showing the components of the RPT device included within the patient interface. [Figure 31] Figure 27 is an exploded view of the patient interface, showing the components of the RPT device. [Figure 32] This is a perspective view of the valve. [Figure 33] Figure 32 is a cross-sectional view of the valve in the closed position. [Figure 34] Figure 32 is a cross-sectional view of the valve, showing the valve in the open position. [Figure 35] Figures 33 and 34 are detailed views of the valve. [Figure 36] Figure 32 is a cross-sectional view of the valve connected to the patient interface and moved to the open position during patient inspiration. [Figure 37] Figure 36 is a cross-sectional side view. [Figure 38] Figure 36 is a cross-sectional side view. [Figure 39] Figure 32 is a cross-sectional view of the valve connected to the patient interface and moved to the closed position during the patient's exhalation. [Figure 40] Figure 39 is a cross-sectional side view. [Figure 41] Figure 39 is a cross-sectional side view. [Figure 42] This is a top view of the first example of a valve. [Figure 43] Figure 42 is a cross-sectional view of the cushion. [Figure 44] This is a top view of the second example of a valve. [Figure 45] Figure 44 is a cross-sectional view of the cushion. [Figure 46] This is a top view of a third example of a valve. [Figure 47]Figure 46 is a cross-sectional view of the cushion. [Figure 48] This is a cross-section of the blower. [Figure 49] Figure 48 is a partial cross-sectional view of the impeller used in the blower. [Figure 50] Figure 48 is a perspective cross-sectional view showing the blower and alternative impeller configurations that can be used. [Figure 51] Figure 48 is a cross-sectional view of the blower and alternative impeller shapes that can be used. [Figure 52] This diagram schematically shows the operation of the valve in Figure 32 and the blower in Figure 48. [Figure 53] This is a flow diagram of the flow through the valve in Figure 32. 4.8 AR / VR Interface [Figure 54] This is a front perspective view of a head-mounted display. [Figure 55] Figure 54 is a rear perspective view of the head-mounted display, showing the interface with speakers. [Figure 56] A perspective view of a patient interface with an audio system. 4.10 Alternative Interface Examples [Figure 57] This is a perspective view of a patient interface, including an RPT device, a head-mounted display interface, and a user interface structure, on the patient's head, as an example of this technology. [Figure 58] This is a side view of the patient interface on the patient's head, as an example of this technology, as shown in Figure 57. [Figure 59] Figure 57 is a front view of the patient interface located above the patient's head, as an example of this technology. [Figure 60] This is a cross-sectional view of the patient interface on the patient's head, as an example of this technology, as shown in Figure 57. [Figure 61] Figure 57 is a front perspective view of the patient interface, an example of this technology. [Figure 62] Figure 57 is a rear perspective view of the patient interface, an example of this technology. [Figure 63]Front perspective view of the patient interface of FIG. 57 with the front case removed, according to an example of the present technology. [Figure 64] Front view of the patient interface of FIG. 57 without the front case, according to an example of the present technology. [Figure 65] Side view of a patient interface including an RPT device, a head-mounted display interface, and a user interface structure, according to an example of the present technology. [Figure 66] Bottom view of the patient interface of FIG. 65, according to an example of the present technology. [Figure 67] Exploded rear view of the patient interface of FIG. 65, according to an example of the present technology. [Figure 68] Exploded front view of the patient interface of FIG. 65, according to an example of the present technology. [Figure 69] Another exploded front view of the patient interface of FIG. 65, according to an example of the present technology. [Figure 70] Exploded view of the user interface structure and casing of the patient interface of FIG. 65, according to an example of the present technology. [Figure 71] Exploded view of a treatment cushion component, an EAV, and a manifold, according to an example of the present technology. [Figure 72] Exploded view of the user interface structure and casing of the patient interface, according to an example of the present technology. [Figure 73] Exploded view of the user interface structure and EAV of FIG. 72. [Figure 74] Cross-sectional view of a patient interface, according to an example of the present technology. [Figure 75] Cross-sectional view of a patient interface, according to an example of the present technology. [Figure 76] Cross-sectional view of a patient interface, according to an example of the present technology. [Figure 77] Cross-sectional view of a patient interface, according to an example of the present technology. [Figure 78] Exploded view of an enclosure plate for a casing, according to an example of the present technology. [Figure 79] This is an enlarged perspective view of the enclosure plate shown in Figure 78, an example of this technology. [Figure 80] This is a front perspective view of a full-face patient interface, an example of this technology. [Figure 81] Figure 80 shows a rear perspective view of a full-face patient interface, an example of this technology. [Figure 82] Figure 80 is a rear view of the full-face patient interface, an example of this technology. [Figure 83] Figure 80 is a cross-sectional view of a full-face patient interface, an example of this technology. [Modes for carrying out the invention]

[0192] Before describing this technology in further detail, please understand that this technology is not limited to the specific examples described herein and is subject to change. Furthermore, please understand that the terms used in this disclosure are intended to illustrate only the specific examples described herein and are not intended to limit them.

[0193] The following explanation is provided in relation to various examples that may share one or more common properties and / or features. It should be understood that one or more features in any one example may be combined with one or more features in another example or any other example. In addition, any single feature or combination of features in any of these examples may constitute further examples. 5.1 Therapy

[0194] In one embodiment, the technology includes a method for treating respiratory diseases, which involves applying positive pressure to the airway entrance of 1000 patients.

[0195] In a specific example of this technology, a positive pressure air supply is provided to the patient's nasal pathway through one or both nostrils.

[0196] In certain examples of this technology, mouth breathing is restricted, limited, or prevented. 5.2 Respiratory Therapy Systems

[0197] In one embodiment, the technology includes a respiratory therapy system for treating respiratory disorders. The respiratory therapy system may include an RPT device 4000 that supplies airflow to a patient 1000 via an air circuit 4170 and a patient interface 3000. 5.3 Patient Interface

[0198] A non-invasive patient interface 3000 according to one aspect of this technology includes, as functional modes, a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilization structure 3300, a ventilation opening 3400, a configuration of connection ports 3600 for connection to an air circuit 4170, and a selective forehead support 3700. In some embodiments, the functional modes may be provided by one or more physical placement elements. In some embodiments, a single physical component may provide one or more functional modes. When in use, the seal-forming structure 3100 is positioned to surround the patient's airway inlet(s) to maintain positive pressure at the patient's airway inlet(s). Thus, the sealed patient interface 3000 is suitable for the delivery of positive pressure therapy.

[0199] If a patient interface cannot comfortably deliver a minimum level of positive pressure to the airway, it may not be suitable for respiratory pressure therapy.

[0200] A patient interface 3000, according to one form of this technology, is constructed and positioned to supply air at a positive pressure higher than the ambient pressure.

[0201] A patient interface 3000 according to one form of this technology is constructed and positioned to supply air at a positive pressure at least 2 cmH2O higher than the surroundings.

[0202] The patient interface 3000 according to one embodiment of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 4 cmH2O relative to the surroundings.

[0203] The patient interface 3000 according to one embodiment of the present technology is constructed and arranged to be able to provide an air supply at a positive pressure of at least 6 cmH2O relative to the surroundings.

[0204] The patient interface 3000 according to one embodiment of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 10 cmH2O relative to the surroundings.

[0205] The patient interface 3000 according to one embodiment of the present technology is constructed and arranged to be able to provide an air supply at a positive pressure of at least 10 cmH2O relative to the surroundings. 5.3.1 Seal formation structure

[0206] In one embodiment of the present technology, the seal formation structure 3100 provides a target seal formation area and may further provide a buffering function. The target seal formation area is an area on the seal formation structure 3100 where a seal may be performed. The area where sealing actually occurs (i.e., the actual sealing surface) may vary daily by the patient in a given treatment session depending on a range of factors (e.g., the placement position of the patient interface on the face, the tension in the positioning and stabilization structure, and the shape of the patient's face).

[0207] In one embodiment, the target seal formation area is arranged on the outer surface of the seal formation structure 3100.

[0208] In a particular embodiment of the present technology, the seal formation structure 3100 is composed of a biocompatible material (e.g., silicone rubber).

[0209] The seal formation structure 3100 according to the present technology may be constructed from a soft, flexible and elastic material, such as silicone.

[0210] In certain embodiments of this technology, a system is provided that includes more than one seal-forming structure 3100. Each seal-forming structure 3100 is configured to accommodate different size and / or shape ranges. For example, the system may include one form of seal-forming structure 3100 suitable for large heads rather than small heads, and another suitable for small heads rather than large heads. 5.3.1.1 Sealing mechanism

[0211] In one embodiment, the seal-forming structure includes a sealing flange using a pressure-assisted sealing mechanism. During use, the sealing flange can readily respond to the positive system pressure within the plenum chamber 3200 and act on its underside to form a tight sealing engagement with the surface. The pressure-assisted mechanism may work in conjunction with elastic tension in the positioning and stabilizing structure.

[0212] In one embodiment, the seal-forming structure 3100 includes a sealing flange and a support flange. The sealing flange includes a relatively thin member with a thickness of less than about 1 mm (e.g., about 0.25 mm to about 0.45 mm). This member extends around the perimeter length of the plenum chamber 3200. The support flange may be relatively thicker than the sealing flange. The support flange is positioned between the sealing flange and the periphery of the plenum chamber 3200 and extends around at least a portion of the perimeter length. The support flange is or includes a spring-like element and functions to support the sealing flange so that it does not buckle during use.

[0213] In one embodiment, the seal-forming structure may include a compression seal or a gasket seal. During use, the compression seal or gasket seal is constructed and positioned such that it is compressed, for example, due to elastic tension in the positioning and stabilizing structure.

[0214] In one embodiment, the seal-forming structure includes a tensioning portion. During use, the tensioning portion is held taut by, for example, an adjacent region of the sealing flange.

[0215] In one embodiment, the seal-forming structure includes a region having an adhesive surface or bonding surface.

[0216] In certain embodiments of this technology, the seal-forming structure may include one or more of the following: a pressure-assisted sealing flange, a compression sealing portion, a gasket sealing portion, a tension portion, and a portion having an adhesive or bonding surface. 5.3.1.2 Nasal bridge or nasal ridge region

[0217] In one embodiment, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal on the nasal bridge region or nasal ridge region of the patient's face when in use.

[0218] In one embodiment, the seal-forming structure includes a saddle-shaped region constructed to form a seal on the nasal bridge region or nasal ridge region of the patient's face when in use. 5.3.1.3 Upper lip area

[0219] In one embodiment, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal when in use on the upper lip region (i.e., the upper lip) of the patient's face.

[0220] In one embodiment, the seal-forming structure includes a saddle-shaped region constructed to form a seal on the upper lip area of ​​the patient's face when in use. 5.3.1.4 Jaw region

[0221] In one embodiment, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal on the jaw region of the patient's face when in use.

[0222] In one embodiment, the seal-forming structure includes a saddle-shaped region constructed to form a seal on the jaw area of ​​the patient's face when in use. 5.3.1.5 Frontal Area

[0223] In one embodiment, the seal-forming structure forms a seal on the forehead area of ​​the patient's face when the seal is in use. In this embodiment, the plenum chamber may cover the eye when in use. 5.3.1.6 Nasal pillow

[0224] In one embodiment, the seal-forming structure of the non-invasive patient interface 3000 includes a pair of nasal puffs or nasal pillows, each of which is constructed and positioned to form a seal with each nostril of the patient's nose.

[0225] A nasal pillow according to one aspect of this technology includes a frustocone, at least a portion of which forms a seal on the underside of the patient's nose; a handle; and a flexible region connecting the lower part of the frustocone to the handle. Furthermore, the structure to which the nasal pillow of this technology is connected includes a flexible region adjacent to the base of the handle. The flexible regions work together to facilitate a universal joint structure that adapts to relative movement (both displacement and angle) between the frustocone and the structure to which the nasal pillow is connected. For example, the frustocone can be displaced axially toward the structure to which the handle is connected. 5.3.2 Plenum Chamber

[0226] The plenum chamber 3200 has a perimeter shape that is complementary to the surface contour of an average human face in the area where a seal is formed during use. During use, the periphery of the plenum chamber 3200 is positioned in close proximity to the adjacent surfaces of the face. Actual contact with the face is provided by the seal-forming structure 3100. The seal-forming structure 3100 may extend substantially around the entire circumference of the plenum chamber 3200 during use. In some embodiments, the plenum chamber 3200 and the seal-forming structure 3100 are formed from a single homogeneous sheet of material.

[0227] In certain forms of this technology, the plenum chamber 3200 does not cover the patient's eyes during use. In other words, the eyes are outside the pressurized volume defined by the plenum chamber. In such forms, treatment compliance may be improved because pressure is reduced and / or wearer comfort is increased.

[0228] In certain forms of this technology, the plenum chamber 3200 is constructed from a transparent material (e.g., transparent polycarbonate). The use of transparent materials can reduce the intrusiveness of the patient interface and may help improve compliance with treatment. The use of transparent materials may also help clinicians confirm the placement and function of the patient interface.

[0229] In a specific form of this technology, the plenum chamber 3200 is constructed from a translucent material. The use of a translucent material can reduce the intrusiveness of the patient interface, thereby helping to improve compliance with treatment. 5.3.3 Positioning and Stabilization Structure

[0230] The seal-forming structure 3100 of the patient interface 3000 of this technology may be held in the sealing position during use by the positioning and stabilizing structure 3300.

[0231] In one embodiment, the positioning and stabilizing structure 3300 provides a holding force that is at least sufficient to overcome the positive pressure effect of the plenum chamber 3200 separating from the face.

[0232] In one embodiment, the positioning and stabilizing structure 3300 provides a holding force to overcome the effects of gravity on the patient interface 3000.

[0233] In one embodiment, the positioning and stabilizing structure 3300 provides a holding force as a safety margin to eliminate the possibility of destructive effects on the patient interface 3000 (e.g., due to tube dragging or accidental interference with the patient interface).

[0234] In one embodiment of this technology, a positioning and stabilization structure 3300 is provided, configured to be worn by a patient during sleep. In one example, the positioning and stabilization structure 3300 has an inconspicuous shape or cross-sectional thickness to reduce the perceived or actual bulk of the device. In one example, the positioning and stabilization structure 3300 includes at least one strap having a rectangular cross-section. In one example, the positioning and stabilization structure 3300 includes at least one flat strap.

[0235] In one embodiment of this technology, a positioning and stabilizing structure 3300 is provided that is configured not to be excessively large or bulky in a way that would interfere with a patient sleeping in a supine position with the posterior region of the patient's head resting on a pillow.

[0236] In one embodiment of this technology, a positioning and stabilizing structure 3300 is provided that is configured not to be excessively large or bulky in a way that would interfere with a patient sleeping in a lateral position with the lateral section of the patient's head resting on a pillow.

[0237] In one embodiment of this technology, the positioning and stabilizing structure 3300 includes a release portion positioned between the front portion and the rear portion of the positioning and stabilizing structure 3300. This release portion is not compressible and may be, for example, a flexible or pliable strap. The release portion is constructed and positioned so as to prevent a situation in which, when a patient lies down with their head on a pillow, the presence of the release portion transmits forces to the rear along the positioning and stabilizing structure 3300 and disrupts the seal.

[0238] In one embodiment of this technology, the positioning and stabilizing structure 3300 includes a strap composed of a laminate of a fabric patient contact layer, a foam inner layer, and a fabric outer layer. In one embodiment, the foam is porous so that moisture (e.g., sweat) can pass through the strap. In one embodiment, the fabric outer layer includes a loop material that engages with a hook material portion.

[0239] In certain embodiments of this technology, the positioning and stabilizing structure 3300 includes an extendable (e.g., extendable with elasticity) strap. For example, the strap may be configured to be taut when in use, directing the force that brings the seal-forming structure into contact with a portion of the patient's face. In one example, the strap may be configured as a tie.

[0240] In one embodiment of this technology, the positioning and stabilizing structure includes a first tie, which is constructed and positioned such that, during use, at least a portion of its lower edge passes over the patient's head to the superior base of the ear and covers a portion of the parietal bone without covering the occipital bone.

[0241] In one embodiment of this technology suitable for a nasal mask or a full-face mask, the positioning and stabilizing structure includes a second tie, which is constructed and positioned such that, when in use, at least a portion of its upper edge passes below the lower earlobe on the underside of the patient's head and covers or rests on the underside of the occipital bone of the patient's head.

[0242] In one embodiment of this technology suitable for a nasal mask or a full-face mask, the positioning and stabilizing structure includes a third tie constructed and positioned to interconnect the first and second ties to reduce the tendency of the first and second ties to move in a divergent direction.

[0243] In certain embodiments of this technology, the positioning and stabilizing structure 3300 includes a flexible and, for example, non-rigid strap. An advantage of this embodiment is that the strap is more comfortable when the patient lies down during sleep.

[0244] In certain embodiments of this technology, the positioning and stabilizing structure 3300 includes a strap configured to be breathable, allowing water vapor to pass through its interior.

[0245] In certain embodiments of this technology, a system is provided comprising more than one positioning and stabilizing structure 3300. Each positioning and stabilizing structure 3300 is configured to provide holding force to accommodate different size and / or shape ranges. For example, the system may include one form of positioning and stabilizing structure 3300 that is suitable for a large head rather than a small head, and another form that is suitable for a small head rather than a large head. 5.3.4 Ventilation vents

[0246] In one embodiment, the patient interface 3000 includes a vent 3400 constructed and positioned to allow the expulsion of exhaled gases, such as carbon dioxide.

[0247] In certain configurations, the ventilator 3400 is configured to allow a continuous ventilation port flow from the inside of the plenum chamber 3200 to the environment, while simultaneously maintaining a positive pressure within the plenum chamber relative to the ambient pressure. The ventilator 3400 is configured to have a ventilation flow rate large enough to reduce rebreathing of CO2 inhaled by the patient while maintaining therapeutic pressure within the plenum chamber during use.

[0248] One form of the ventilation opening 3400 according to this technology includes a plurality of holes (for example, about 20 to 80 holes, or about 40 to 60 holes, or about 45 to 55 holes).

[0249] The ventilation opening 3400 may be located within the plenum chamber 3200. Alternatively, the ventilation opening 3400 may be located within a separation structure such as a swivel. 5.3.5 Decoupled structures (multiple structures possible)

[0250] In one embodiment, the patient interface 3000 includes at least one decoupling structure (e.g., a swivel or bulbolar fovea). 5.3.6 Connection Ports

[0251] Connection port 3600 allows connection to the air circuit 4170. 5.3.7 Forehead support

[0252] In one embodiment, the patient interface 3000 includes a forehead support 3700. 5.3.8 Choking prevention valve

[0253] In one configuration, the patient interface 3000 includes an asphyxiation prevention valve. 5.3.9 Ports

[0254] In one embodiment of this technology, the patient interface 3000 includes one or more ports that allow access to the volume within the plenum chamber 3200. In one embodiment, this allows a clinician to supply supplemental oxygen. In another embodiment, this allows for direct measurement of the gas (e.g., pressure) within the plenum chamber 3200. 5.3.10 Internal Unit

[0255] As shown in Figures 7 to 22, some forms of the patient interface may be built-in units. For example, the patient interface may not need to connect to an external device to receive the pressurized airflow. Instead, the patient interface itself may include a motor to deliver the pressurized airflow directly to the patient.

[0256] In some forms, this can make the patient interface more portable, which may be particularly beneficial for patients who are traveling. For example, patients may be able to pack smaller, more portable components. This may facilitate the continuation of treatment while the patient is away from home.

[0257] In some forms, an integrated patient interface may facilitate better sleep for the patient or their bed partner. For example, the patient may not need to be connected to an RPT device, and their movement during sleep may be restricted. This may allow the patient to turn over or move in other ways without being restrained during sleep. Similarly, if the patient can sleep through the night, their bed partner may also experience better sleep.

[0258] In certain configurations, patients (and / or their bed partners) may dislike the cumbersome nature of wires, tubes, and / or cords, and may find the medical appearance of the patient interface aesthetically unappealing. This can lead to decreased compliance with treatment. Reducing the external accessories of an integrated patient interface increases the likelihood of the patient using the interface. For example, as described below, the material of the patient interface, combined with the lack of external accessories, may reduce the medical feel of the patient interface.

[0259] In some forms, providing a single unit can be more intuitive for patients. For example, patients may only need to operate a single device, which can simplify the steps required to learn how to use it.

[0260] As will be explained below, the patient interfaces shown in Figures 7 to 22 may be similar to the patient interface 3000 described above (see, for example, Figure 3A), and only some of the similarities and differences may be explained. 5.3.10.1 Full-face interface

[0261] As shown in Figures 7-16, some forms of patient interfaces are full-face patient interfaces. For example, the patient interface may form seals around the patient's nose and / or mouth so that pressurized air is delivered to the patient's airway through either the patient's nose and / or the patient's mouth.

[0262] As shown in Figures 7 to 9, the first version of the full-face patient interface 6000 may include a seal-forming structure 6100, a plenum chamber 6200, a positioning and stabilizing structure 6300, and a flow generator casing 6400.

[0263] The seal-forming structure 6100 may be made of a flexible material and may be comfortable when in contact with the patient's face. The seal-forming structure 6100 may be made of, for example, a silicone material. Alternatively or additionally, the seal-forming structure 6100 may be made of a fibrous material. The seal-forming structure may have a frame made of a material harder than the sealing portion (e.g., plastic or polycarbonate), and the frame may be attached to the casing 6408 as described in relation to Figure 31. The sealing portion and / or frame may have gas exhaust vents having one or more holes for exhausting exhaled gases to the surroundings. Also, particularly if the patient interface is a full-face mask or a nasal-mouth mask, the seal-forming structure and / or casing (described below) may include an asphyxiation prevention valve (AAV) that allows the patient to inhale ambient air when the patient interface is not connected to a power source (e.g., due to a power outage).

[0264] In the illustrated example, the seal-forming structure 6100 may have a substantially low profile. As mentioned above, patients may feel uncomfortable wearing large devices and therefore may decide against continuing treatment. Therefore, the seal-forming structure 6100 may have a minimal sealing area (e.g., the area within the seal-forming structure 6100).

[0265] In certain configurations, the nasal seal 6104 of the seal-forming structure 6100 does not need to be in contact with the nasal prominence of the patient. For example, the seal-forming structure 6100 may seal around the rim of the patient's nostrils while avoiding contact with the nasal bridge. This may be more comfortable for the patient because less of the face is in contact with the seal and subjected to treatment pressure.

[0266] In some configurations, the seal-forming structure 6100 does not extend substantially beyond the plenum chamber 6200 and / or the flow generator casing 6400. For example, the height of the plenum chamber 6200 and / or the flow generator casing 6400 may be substantially the same as the height of the seal area (e.g., measured from the patient's lips below the anterior nasal cavity). In other examples, the plenum chamber 6200 and / or the flow generator casing 6400 may extend below the seal-forming structure 6100 (e.g., towards the supramentone) but not substantially above the seal-forming structure (e.g., above the anterior nasal muscle, above the patient's nasal bridge). This may contribute to a thinner patient interface 6000. For example, the plenum chamber 6200 and / or the flow generator casing 6400 may be designed so as not to substantially obstruct the patient's line of sight.

[0267] The positioning and stabilizing structure 6300 may also be connected to the flow generator casing 6400. As will be described later, the flow generator casing 6400 is connected to the plenum chan 6200 and the seal-forming structure 6100. Therefore, the positioning and stabilizing structure 6300 may provide tensile force to maintain the seal-forming structure 6100 in the sealing position on the patient's face.

[0268] The positioning and stabilizing structure 6300 may be formed as a headgear and may include a front strap 6304. The front strap 6304 may be in contact with the patient's face between each eye and ear and may pass over the patient's head. In other words, the front strap 6304 may be in contact with the patient's cheeks and may overlap the frontal bone and / or parietal bone of the patient's head.

[0269] The front strap 6304 may include an end 6308 that connects to the flow generator casing 6400. In some examples, the end 6308 may be permanently connected to the flow generator casing 6400 (e.g., via adhesive, stitching, welding, etc.). In other examples, the end 6308 may be detachably connected to the flow generator casing 6400 (e.g., via mechanical fasteners, hook and look materials, magnets, etc.). Although not shown, the end 6308 may be directly connected to the plenum chamber 6200 (e.g., detachably or permanently connected).

[0270] In some forms, the front strap 6304 may be made of textile or other comfortable material (e.g., a flexible and soft-to-the-touch material). Textile material may promote patient compliance as it closely resembles bed clothing rather than a medical device. Improved comfort and aesthetics may allow the patient to continue wearing the patient interface 6000 and continue treatment.

[0271] As shown in Figures 7 and 8, a particular form of the front strap 6304 may include one or more rigidizers 6312. The rigidizers 6312 may be enclosed in the fibrous material of the front strap 6304 so that the rigidizers 6312 are not exposed (for example, Figure 7 shows the contour of the rigidizer 6312 under the fibrous material of the front strap 6304). Enclosing the rigidizers 6312 in the fibrous material may improve patient comfort by limiting the patient's contact with the uncomfortable material.

[0272] In certain embodiments, a single rigidizer 6312 may extend around the front strap 6304 (e.g., substantially between the ends 6308). The rigidizer 6312 may limit the extension of the top strap 6304 (and thus the seal-forming structure 6100) in order to maintain it in a desired position. Alternatively, multiple rigidizers 6312 may be provided around the top strap 6304. Gaps may exist between different rigidizers 6312, which may result in localized stretching.

[0273] Alternatively, the top strap 6304 may include padding or cushioning material. For example, the top strap 6304 may include padding instead of the rigidizer 6312, or it may include padding in addition to the rigidizer 6312. The padding may be formed from a compressible material such as foam. The padding may enhance comfort for patients sleeping on their sides and may further promote the continuation of treatment.

[0274] As shown in Figures 7 and 8, some forms of the front strap 6304 may include a button or user engagement device 6314. The button 6314 may be connected to a latch (not shown). When the patient activates the button 6314, the button 6314 and the latch may move together. As described below, the button 6314 may be detachably connected to a positioning and stabilization structure 6300.

[0275] The positioning and stabilizing structure 6300 may in some forms further include an upper back strap 6316. The upper back strap 6316 may contact the back of the patient's head when in use. For example, the upper back strap 6316 may contact the patient's head over each ear (e.g., overlapping the temporal bone) and extend toward the back of the patient's head (e.g., overlapping the occipital bone).

[0276] In some configurations, the upper back strap 6316 may be connected to the front strap 6304. For example, the upper back strap 6316 may be connected to the front back strap 6304 in a position that is superior to the patient's ears during use (e.g., so that the upper back strap 6316 does not cross the patient's ears). The upper back strap 6316 may be permanently connected to the front strap 6304, and in other examples, the upper back strap 6316 may be detachably connected to the front strap 6304.

[0277] As shown in Figures 7 and 8, the upper back strap 6316 may be made of an elastic material. For example, the upper back strap 6316 may be more elastic and stretchable than the front strap 6304. The elasticity of the upper back strap 6316 may allow the positioning and stabilizing structure 6300 to fit various patients' heads and provide tensile force to maintain the sealing position of the seal-forming structure 6100. The elastic material may be as comfortable as the fibrous material of the front strap 6304.

[0278] In other configurations, the upper back strap 6316 may be formed of a non-stretchable material.

[0279] In some forms, the positioning and stabilizing structure 6300 may further include a lower back strap 6320. The lower back strap 6320 may contact the back of the patient's head when in use. For example, the lower back strap 6320 may contact the patient's head below each ear (e.g., overlapping the masseter muscle) and extend toward the back of the patient's head (e.g., overlapping the occipital bone).

[0280] The lower back strap 6320 may be connected to the front strap 6304. For example, the lower back strap 6320 may be connected to the front strap 6304 in a position below the patient's ears during use (for example, so that the lower back strap 6320 does not cross the patient's ears). As shown in Figures 7 to 9, the lower back strap 6320 may be detachably connected to the front strap 6304 (for example, by magnets as shown in Figures 7 and 8, or by hook-and-loop material as shown in Figure 9). Alternatively, the lower back strap 6320 may be permanently connected to the front strap 6304.

[0281] As shown in Figures 7 and 8, the lower back strap 6320 may be made of an elastic material. For example, the lower back strap 6320 may have greater elasticity and stretchability than the front strap 6304. The upper and lower back straps 6316 and 6320 may be made of the same material, or they may have different elasticity. The elasticity of the lower back strap 6320 may allow the positioning and stabilizing structure 6300 to fit various patients' heads and provide tensile force to maintain the sealing position of the seal-forming structure 6100. The elastic material may be as comfortable as the fibrous material of the front strap 6304.

[0282] As shown in Figures 7 and 8, the connector strap 6324 may connect the upper and lower back straps 6316 and 6320. The connector strap 6324 may overlap the patient's occipital bone during use. The connector strap 6324 may restrict relative movement between the upper and lower back straps 6316 and 6320.

[0283] As shown in Figure 9, an alternative version of the positioning and stabilizing structure 6350 may be used and connected to the flow generator casing 6400. The positioning and stabilizing structure 6350 may be a knitted headgear (e.g., at least part of which is made of fiber). The positioning and stabilizing structure 6350 may be formed as a single piece (e.g., the individual straps may not be separated from each other).

[0284] In some forms, the positioning and stabilizing structure 6350 may contact the patient's head in substantially the same manner as the positioning and stabilizing structure 6300 (e.g., in substantially the same position).

[0285] In some forms, a portion of the positioning and stabilizing structure 6350 may include mesh material. Because the mesh and fibers constituting the positioning and stabilizing structure 6350 have different expandability, the positioning and stabilizing structure 6350 may stretch as predetermined.

[0286] Parts of the positioning and stabilization structure 6350 may be made rigid. For example, stitches may be applied to parts of the positioning and stabilization structure 6350 to limit where the extension of the positioning and stabilization structure 6350 is located.

[0287] In certain configurations, the stitches can also provide structural rigidity to the positioning and stabilizing structure 6350. For example, the positioning and stabilizing structure 6350 may maintain its three-dimensional shape when not worn by a patient (similar to the positioning and stabilizing structure 6300 with a residizer 6312, for example).

[0288] Continuing to refer to Figure 9, the positioning and stabilization structure 6350 does not have to be permanently connected to the flow generator casing 6400 (or to the plenum chamber). Instead, the positioning and stabilization structure 6350 may be detachably connected.

[0289] For example, the flow generator casing 6400 may include a strap opening 6402 through which the strap of the positioning and stabilizing structure 6350 can pass. The patient may adjust the length of the strap through which it passes to control the tension provided by the positioning and stabilizing structure 6350.

[0290] In certain configurations, the positioning and stabilization structure 6350 may include hook and loop material (not shown) to maintain the strap in a desired position.

[0291] The flow generator casing 6400 shown in Figures 7-9 may include a front case 6404 connected to a rear case 6406. The front case 6404 may be connected to the rear case 6406 to house electrical components, which will be described later.

[0292] In some configurations, the rear case 6406 may be larger than the front case 6404. The front case 6404 may be fitted into the rear case 6406 in a substantially flush position.

[0293] For example, the front and rear cases 6404 and 6406 may have curvatures that are approximately the same as the other curvatures. When the rear case 6406 receives the front case 6404, the curvatures may be aligned such that a substantially smooth transition occurs between the front cases 6404 and 6406 and the rear cases 6404 and 6406.

[0294] In some configurations, the rear case 6406 may be covered with a fibrous material. The rear case 6406 is located closer to the patient's face than the front case 6404, and the fibrous material may help improve patient comfort and / or the overall aesthetics of the patient interface 6000.

[0295] In some configurations, the front case 6404 and / or the rear case 6406 may be constructed in different colors and / or different finishes (e.g., gloss, matte, etc.). The patient may select the colors and / or finishes based on their personal preferences to enhance the overall aesthetic appeal of the patient interface 6000.

[0296] In some configurations, the front and rear cases 6404, 6406 may be detachably connected. For example, the front case 6404 may be cut from the rear case 6406 to expose the cavity 6408 (see, for example, Figure 31) which houses the electrical components. The front and rear cases 6404, 6406 may be detachably connected by snap fitting, friction fitting, press fitting, and / or magnetic engagement.

[0297] Figures 10 to 12 may show alternative examples of the first version of the full-face patient interface 6000. As described below, the full-face patient interface 6000 shown in Figures 7 to 9 may differ from the full-face patient interface in Figures 10 to 12 in the means by which power is supplied to the patient interface 6000. For example, the patient interface 6000 in Figures 7 to 9 uses a power cord 6020 to connect to a battery 6010 separate from the patient interface 6000, while the patient interface 6000 in Figures 10 to 12 uses a battery 6030 directly connected to the patient interface 6000.

[0298] As shown in Figure 13, the second version of the full-face patient interface 7000 may include a seal-forming structure 7100, a plenum chamber 7200, a positioning and stabilization structure 7300, and a flow generator casing 7400. The second version of the full-face patient interface 7000 may be similar to the first version of the full-face patient interface 6000. Therefore, only some similarities and differences may be described below. For example, similar functions may include similar reference numbers with "1000" added.

[0299] In some configurations, the flow generator casing 7400 includes a central section 7430 and a pair of lateral sections 7432 (one of which is shown in Figure 13). The central section 7430 may be positioned adjacent to the plenum chamber 7200 (for example, aligned with the patient's sagittal plane during use). The lateral sections 7432 may be positioned on either side of the central section 7430.

[0300] In some forms, the central section 7430 and the lateral section 7432 may each have curvature. The curvature of each section 7430, 7432 may be substantially the same so that sections 7430, 7432 form a substantially smooth interface (e.g., without sharp corners).

[0301] In certain configurations, the curvature of the central section 7430 and the lateral sections 7432 may be similar to the curvature of the patient's face (e.g., the mandible and / or maxilla). The curvature of the flow generator casing 7400 may also help to create a smaller shape for the patient interface 7000 in order to reduce slight line obstructions and make the patient interface 7000 more comfortable to wear.

[0302] As shown in Figure 13 (and Figure 15), the central section 7430 may extend beyond at least a portion of the seal-forming structure 7100 (for example, above the nasal portion 7104 of the seal). For example, the center of the central section 7430 (for example, intersecting the sagittal plane during use) may be above the anterior nasal portion of the patient during use.

[0303] In some configurations, the central section 7430 may be removable from the lateral sections 7432. The central section 7430 may be formed from a rigid material (e.g., plastic) and may protect the electrical components of the patient interface 7000.

[0304] Figures 14 to 16 may show alternative examples of a second version of the full-face patient interface 7000. As described below, the full-face patient interface 7000 shown in Figure 13 may differ from the full-face patient interfaces shown in Figures 14 to 16 in terms of the power supplied to the patient interface 7000. For example, the patient interface 7000 in Figure 13 uses a power cord 6020 to connect to a battery 6010 separate from the patient interface 7000, while the patient interfaces 7000 in Figures 14 to 16 use a battery 6035 directly connected to the patient interface 7000.

[0305] In some embodiments, the battery 6035 may include a curvature that substantially replicates the curvature of the front strap 7304. This may allow for substantially flush engagement between the battery 6035 and the front strap 7304 (e.g., there may be no sharp corners between the battery 6035 and the front strap 7304). In addition, the battery 6035 and the front strap 7304 may form a substantially smooth curvature between the ends 7308. This may create a smaller profile (e.g., compared to the first version shown in Figures 10 to 12). A smaller profile may provide a more aesthetically pleasing appearance and may bring the center of gravity of the patient interface closer to the patient's head. 5.3.10.2 Nasal Interface

[0306] As shown in Figures 17 to 22, some forms of patient interfaces are nasal patient interfaces. For example, a patient interface may form a seal around the patient's nostrils to allow pressurized air to be delivered through the patient's nose into the patient's airway. A seal may not be formed around the patient's mouth so that the patient's mouth remains exposed to ambient pressure.

[0307] As shown in Figure 17, the first version of the nasal patient interface 8000 may include a seal-forming structure 8100, a plenum chamber 8200, a positioning and stabilizing structure 8300, and a flow generator casing 8400.

[0308] The seal-forming structure 8100 may be constructed from a flexible material and may be comfortable when in contact with the patient's face. The seal-forming structure 8100 may be formed from, for example, a silicone material. Alternatively or additionally, the seal-forming structure 8100 may be formed from a fibrous material.

[0309] In the illustrated example, the seal-forming structure 8100 may have a substantially low profile. As mentioned above, patients may experience discomfort from wearing large devices and therefore may decide against continuing treatment. Therefore, the seal-forming structure 8100 may minimize the sealing area (e.g., the area within the seal-forming structure 8100).

[0310] In certain configurations, the nasal seal 8104 of the seal-forming structure 8100 does not need to contact the nasal prominence of the patient. For example, the seal-forming structure 6100 may seal around the rim of the patient's nostrils while avoiding contact with the nasal bridge. This may be more comfortable for the patient because less of the face is in contact with the seal and subjected to treatment pressure.

[0311] In some configurations, the seal-forming structure 8100 does not need to extend substantially beyond the plenum chamber 8200 and / or flow generator casing 8400. For example, the height of the plenum chamber 8200 and / or flow generator casing 8400 may be substantially the same as the height of the seal area (e.g., measured from the patient's lips below the anterior nasal cavity). In other configurations, the plenum chamber 8200 and / or flow generator casing 8400 may extend beyond the seal-forming structure 8100 (e.g., upward), but not substantially upward (e.g., above the anterior nasal muscle, above the patient's nasal bridge). This may contribute to a thinner patient interface 8000. For example, the plenum chamber 8200 and / or flow generator casing 8400 may not substantially obstruct the patient's line of sight. Furthermore, there are no tubes or forehead supports extending upward between the patient's eyes.

[0312] In some configurations, the positioning and stabilizing structure 8300 may be connected to the flow generator casing 8400. As described later, the plenum chamber 8200 and the seal-forming structure 8100 are connected to the flow generator casing 8400. Thus, the positioning and stabilizing structure 8300 may provide tensile force to maintain the seal-forming structure 8100 in the sealing position on the patient's face.

[0313] The positioning and stabilizing structure 8300 may be formed as a headgear and may include a front strap 8304. The front strap 8304 may be in contact with the patient's face between each eye and ear and may pass over the patient's head. In other words, the front strap 8304 may be in contact with the patient's cheeks and may overlap the frontal bone and / or parietal bone of the patient's head.

[0314] In some configurations, the front strap 8304 may include an end 8308 that connects to the flow generator casing 8400. In some examples, the end 8308 may be permanently connected to the flow generator casing 8400 (e.g., via adhesive, stitching, welding, etc.). In other examples, the end 8308 may be detachably connected to the flow generator casing 8400 (e.g., via press-fit, snap-fit, friction-fit, etc.). Although not shown, the end 8308 may instead be directly connected to the plenum chamber 8200 (e.g., detachably or permanently).

[0315] In certain configurations, the flow generator casing 8400 may extend beyond the seal-forming structure 8100 (for example, in the rearward direction during use). The end 8450 of the flow generator casing 8400 may form a substantially flush connection with the end 8308 of the front strap 8304. Thus, when connected to the front strap 8304, the end 8450 of the flow generator casing 8400 may form part of the positioning and stabilization structure 8300.

[0316] In some forms, the front strap 8304 may be constructed from a woven fabric or other comfortable material (e.g., a flexible and soft-to-the-touch material). Textile materials may facilitate patient compliance as they closely resemble bed clothing rather than a medical device. Improved comfort and aesthetic appeal may encourage patients to continue wearing the patient interface 8000 and to continue treatment.

[0317] In some forms, the front strap 8304 may include one or more rigidizing elements. As shown in Figure 17, certain forms of the front strap 8304 may include one or more rigidizers (not shown). The rigidizers may be enclosed by the fibrous material of the front strap 8304 so that the rigidizers are not exposed (for example, Figure 17 shows the rounded shape of the front strap 8304 which can be maintained by the rigidizers beneath the fibrous material of the front strap 8304). By enclosing the rigidizers within the fibrous material, the patient's contact with uncomfortable material is limited, which may improve patient comfort.

[0318] In certain embodiments, a single rigidizer 6312 may extend around the front strap 6304 (e.g., substantially between the ends 6308). The rigidizer 6312 may limit the extension of the top strap 6304 (and thus the seal-forming structure 6100) in order to maintain it in a desired position. Alternatively, multiple rigidizers 6312 may be provided around the top strap 6304. Gaps may exist between different rigidizers 6312, which may result in localized stretching.

[0319] Alternatively, the top strap 8304 may include padding or cushioning material. For example, the top strap 8304 may include padding instead of the rigidizer, or padding in addition to the rigidizer. The padding also helps to provide the three-dimensional shape of the front strap 8304. The padding may be formed from a compressible material such as foam. The padding can enhance comfort for patients sleeping on their sides and may further promote the continuation of treatment.

[0320] In some forms, the positioning and stabilizing structure 8300 may further include an upper back strap 8316. The upper back strap 8316 may contact the back of the patient's head when in use. For example, the upper back strap 8316 may contact the patient's head over each ear (e.g., overlapping the temporal bone) and extend toward the back of the patient's head (e.g., overlapping the occipital bone).

[0321] In some configurations, the upper back strap 8316 may be connected to the front strap 8304. For example, the upper rear strap 8316 may be connected to the front strap 8304 in a position above the patient's ears during use (for example, so that the upper rear strap 8316 does not cross the patient's ears). In some configurations, the upper back strap 8316 may be permanently connected to the front strap 8304, but in other configurations, the upper back strap 8316 may be detachably connected to the front strap 8304.

[0322] As shown in Figure 17, several forms of the upper back strap 8316 may be constructed from an elastic material. For example, the upper back strap 8316 may be more elastic or expandable than the front strap 8304. The elasticity of the upper back strap 8316 allows the positioning and stabilizing structure 8300 to fit various patient heads, while also providing tensile force to maintain the seal position of the seal-forming structure 8100. The elastic material may also be as comfortable as the fibrous material of the front strap 8304.

[0323] In other embodiments, the upper back strap 8316 may be formed from a non-stretchable material.

[0324] In some configurations, the flow generator casing 8400 in Figure 17 may include a front case 8404 connected to a rear case 8406. The front case 8404 may be connected to the rear case 8406 to house electrical components, which will be discussed later.

[0325] In some configurations, the rear case 8406 may be larger than the front case 8404. The front case 8404 may be fitted into the rear case 8406 in a substantially flush position.

[0326] For example, the front case 8404 and the rear case 8406 may each contain substantially the same curvature as the other curvatures. When the rear case 8406 accepts the front case 8404, the curvatures may be aligned such that a substantially smooth transition occurs between the front cases 8404, 8406 and the rear cases 8404, 8406.

[0327] In some configurations, the rear case 8406 may be covered with a fibrous material. The rear case 8406 is located closer to the patient's face than the front case 8404, and the fibrous material may help improve patient comfort and / or the overall aesthetics of the patient interface 8000.

[0328] In some configurations, the front case 8404 and / or the rear case 8406 may be constructed in different colors and / or different finishes (e.g., gloss, matte, etc.). The patient may select the colors and / or finishes based on their personal preferences to enhance the overall aesthetic appeal of the patient interface 8000.

[0329] In some configurations, the rear case 8406 may protrude by a certain distance from the plenum chamber 8200. For example, the distance between the front case 8404 and the plenum chamber 8200 may be less than the similar distance measured in the full-face patient interfaces 6000 and 7000 described above. The rear case 8406 may be smaller than the rear case 6406. The extended distance from the patient's face may provide additional space for mounting the electrical components of the patient interface.

[0330] In some embodiments, the casing, e.g., the top surface 8452 of the casing, e.g., the rear case 8406 and / or the front case 8404, may include at least one air opening 8454 that can provide fluid communication between the cavity within the flow generator casing 8400 and the surroundings. As shown in Figure 17, the top surface 8452 may have one opening 8454 formed as a slot extending across the top surface 8542. The opening 8454 may be the inlet for the flow generator (described below). For example, the flow generator may draw ambient air through the opening 8454, pressurize it, and distribute it to the patient. The opening 8454 may be a slot or space that remains or is formed when the front and rear cases are connected.

[0331] In some configurations, the front and rear cases 8404, 8406 may be detachably connected to each other. For example, the front case 8404 may be detached from the rear case 8406 to expose a cavity 6408 (see, for example, Figure 31) that can house electrical components. The front and rear cases 8404, 8406 may be detachably connected by snap fitting, friction fitting, press fitting, and / or magnetic engagement.

[0332] Figures 18 and 19 may show alternative examples of the first version of the nasal patient interface 8000. As described below, the nasal patient interface 8000 shown in Figure 17 may differ from the nasal patient interfaces shown in Figures 18 and 19 in terms of the power supplied to the patient interface 8000. For example, the patient interface 8000 in Figure 17 uses a power cord 6020 to connect to a separate battery 6010 (see, for example, Figure 33), while the patient interfaces 8000 in Figures 18 and 19 use a battery 6035 directly connected to the patient interface 8000.

[0333] In some embodiments, the battery 6035 may include a curvature that substantially replicates the curvature of the front strap 9304. This may allow for substantially flush engagement between the battery 6035 and the front strap 9304 (e.g., there may be no sharp corners between the battery 6035 and the front strap 9304). Furthermore, the battery 6035 and the front strap 9304 may form a substantially smooth curvature between the ends 9308. This may create a smaller profile (e.g., compared to the first version shown in Figures 10 to 12). A smaller profile may provide a more aesthetically pleasing appearance and may bring the center of gravity of the patient interface closer to the patient's head.

[0334] As shown in Figure 20, the second version of the nasal patient interface 9000 may include a seal-forming structure 9100, a plenum chamber 9200, a positioning and stabilizing structure 9300, and a flow generator casing 9400. The second version of the nasal patient interface 9000 may be similar to the first version of the nasal patient interface 8000. Therefore, only some similarities and differences may be described below. For example, similar functions may include similar reference numbers with "1000" added.

[0335] In some configurations, the flow generator casing 9400 may include a rear case 9404 and a front case 9406. The front case 9404 may be connected (e.g., removable or permanently) to the rear case 9406 to enclose a cavity (not shown).

[0336] The front case 9404 and the rear case 9406 may be of approximately the same height. In other words, the front case 9404 may not be receptive to the rear case 9406, as in the first version of the nasal patient interface 8000 (see, for example, Figures 17-19). Instead, the outer edge of the front case 9404 may be in contact with the outer edge of the rear case 9406. This interface may be substantially smooth to limit patient discomfort caused by sharp edges.

[0337] In some embodiments, a gap or opening 9454 may be formed within the flow generator casing. This may be similar to an opening 8454 and may function as an inlet for the flow generator. However, the opening 9454 may be formed between the front case 9404 and the rear case 9406, on the surfaces of the front cases 9404, 9406. Other examples may include at least one opening on the surface of either the front case 9404 or the rear case 9406 (instead of or in addition to the gap between the cases 9404, 9406).

[0338] Figures 21 and 22 may show alternative examples of a second version of the full-face patient interface 9000. As described below, the full-face patient interface 9000 shown in Figure 20 may differ from the full-face patient interfaces shown in Figures 21 and 22 in terms of the power supplied to the patient interface 9000. For example, the patient interface 9000 in Figure 20 uses a power cord 6020 to connect to a battery 6010 separate from the patient interface 9000, while the patient interfaces 9000 in Figures 21 and 22 use a battery 6035 directly connected to the patient interface 9000.

[0339] In some embodiments, the battery 6035 may include a curvature that substantially replicates the curvature of the front strap 9304. This may allow for substantially flush engagement between the battery 6035 and the front strap 9304 (e.g., there may be no sharp corners between the battery 6035 and the front strap 9304). Furthermore, the battery 6035 and the front strap 9304 may form a substantially smooth curvature between the ends 9308. This may create a smaller profile (e.g., compared to the first version shown in Figures 10 to 12). A smaller profile may provide a more aesthetically pleasing appearance and may bring the center of gravity of the patient interface closer to the patient's head.

[0340] The patient interfaces 8000 and 9000 may include smaller flow generator casings 8400 and 9400 than the flow generator casings 6400 and 7400. In some forms (not shown), the nasal patient interfaces 8000 and 9000 may further include a mouth seal while retaining the smaller flow generator casings 8400 and 9400. The smaller flow generator casings 8400 and 9400 may be equipped with a small blower, which may reduce noise disturbance to the patient or bed partner. 5.3.10.3 Power supply

[0341] As described above, patients wearing patient interfaces may experience discomfort due to being surrounded by cables and wires. Cables or wires may restrict the patient's movement while wearing the device. Wires and cables may also give the patient interface a medical feel, which may contribute to reduced compliance.

[0342] However, wires and cables generally connect the patient interface to the RPT device, and the RPT device requires power to supply pressurized airflow. The built-in patient interface described above includes a flow generator (e.g., within the flow generator casing 6400), but still requires power to operate.

[0343] Therefore, the illustrated example may power the patient interface without substantially compromising the aesthetically pleasing elements for promoting compliance as described above. 5.3.10.3.1 Remote Power Supply

[0344] As shown in Figure 23, a battery 6010 may be provided to supply power to one embodiment of the patient interface. The battery 6010 may store charge used to supply power to the electrical elements of the patient interface (e.g., flow generators, sensors, etc.).

[0345] In some configurations, the battery 6010 is a rechargeable battery and may be reused multiple times. In other configurations, the battery 6010 is a disposable battery and must be replaced after a predetermined number of usage hours.

[0346] As shown in Figures 8, 9, 17, and 20, a power cord 6020 may be connected to each patient interface. The other end of the power cord (not shown) may be connected to a battery 6010. The power cord may transmit electrical energy from the battery 6010 to the electrical components of the patient interface.

[0347] The patient interface can be used at any distance from the wall outlet, which may be beneficial for the patient. Although the Code 6020 still extends from the patient interface, the patient may still experience greater freedom in both movement and location of use.

[0348] As shown in Figures 8, 17, and 20, the power cord 6020 may be connected to the front strap 6304. For example, a socket (not shown) may detachably receive the power cord 6020. The socket may be located on the upper part of the front strap 6304 (for example, close to the patient's arsenal when worn).

[0349] In some configurations, the wires (not shown) may be contained within the fibrous material of the front strap 6304. The wires may be electrically connected to sockets and electrical components within the flow generator casing 6400. Thus, electrical energy may be transmitted between the battery and the electrical components.

[0350] In certain configurations, the front strap 6304 may include a rigidizer 6312 to limit the extension of the wire. For example, the wire may extend within the front strap but may not be able to extend substantially without damage. The rigidizer 6312 may limit the extension of the front strap 6304 to protect the wire.

[0351] As shown in Figure 9, the alternative version includes a socket (not shown) on the flow generator casing 6400 and a power cord 6020 detachably connected to the socket. In this configuration, power from the battery 6010 is delivered directly to the flow generator casing 6400, so the wiring through the front strap 6304 may not be required. However, if electrical components (e.g., sensors) are connected to the front strap 6304, the wiring may still be present.

[0352] In some configurations, the patient interface may include sockets in both the front strap 6304 and the flow generator casing 6400. The patient may connect the power cord 6020 to either socket based on patient comfort and / or patient preference. 5.3.10.3.2 Power Supply Connection

[0353] As shown in Figures 10-12, 14-16, 18, 19, 21, and 22, a battery 6030 may be provided to supply power to one embodiment of the patient interface. The battery 6030 may store charge used to supply power to the electrical elements of the patient interface (e.g., flow generators, sensors, etc.). Conductors, such as wires, may extend from the battery to the blower along the straps of the positioning and stabilizing structure.

[0354] In some configurations, the battery 6030 is a rechargeable battery that can be reused multiple times. In other configurations, the battery 6030 is a disposable battery that needs to be replaced after a predetermined number of usage hours.

[0355] Unlike battery 6010, battery 6030 may be connected directly to each patient interface. This means that a power cord may not be required to connect the battery to the patient interface in order to power various electrical components.

[0356] In the illustrated example, the upper region of the front strap 6304 (e.g., the portion covering the frontal and / or parietal bones) may include a battery dock 6328. The battery dock 6328 may have a shape complementary to the battery 6030 so that the battery 6030 is removably received on the battery dock 6328.

[0357] In some configurations, the button 6314 may be located close to the battery dock 6328. For example, when the battery 6030 is located on the battery dock 6328, it may engage with a projection. The projection may engage with the battery 6030 and hold the battery 6030 in place. The button 6314 can be activated to move the projection relative to the battery 6030, thereby removing the battery 6030 from the battery dock 6328 (for example, to recharge and / or replace it).

[0358] Figures 14–16 show an alternative battery 6035 connected to a front strap 7304 of the patient interface 7000. The battery 6035 may include a selectively activatable button 6037. A latch (not shown) may be connected to either button 6037 such that the latch moves with the movement of the button 6037. The latch may selectively engage the front strap 7304 (for example, near the battery dock 7328 shown in Figure 13) and selectively detach the battery 6035 from the patient interface 7000. Figures 19, 20, 21, and 22 similarly show an alternative battery 6035 with a button 6037.

[0359] In some configurations, the battery 6030 may be covered or wrapped in a fibrous material (e.g., the same or similar material as the front strap 6304). This can give the patient interface with the battery 6030 a non-medical feel, similar to a positioning and stabilizing structure.

[0360] In some configurations, the battery 6030 may be formed with curved or rounded edges and / or sides. This may reduce sharp edges that could cause discomfort to the patient. In addition, the curvature of the battery 6030 may form a smooth (or relatively smooth) interface between the battery 6030 and the front strap 6030. This may help provide a more comfortable and aesthetically pleasing low-profile design for the patient.

[0361] In some configurations, the patient interface may include at least one socket and a battery dock 6328. In other words, the patient may power the patient interface using either a battery 6010 and a power cord 6020, or a battery 6030 attached to the battery dock 6328. The patient may use either battery 6010 or 6030 based on their preference. 5.3.10.3.3 Charging Dock

[0362] As shown in Figures 24 and 25, the patient interface may be connected to the charger 6040 to charge the battery 6030. Although Figures 24 and 25 show the full-face patient interface 6000, any patient interface (e.g., patient interfaces 7000, 8000, 9000) may be used with the charger 6040. Furthermore, either battery (e.g., battery 6030 or battery 6035) may be connected to the patient interface and recharged using the charger 6040.

[0363] In some forms, the charger 6040 may include a base 6042 and a charging dock 6044 extending perpendicularly from the charging base 6042. The charging dock 6044 may include a grooved surface that detachably receives a patient interface (e.g., the front strap 6304 of the positioning and stabilization structure 6300). The grooved surface may include an electrical connector (not shown) that forms an electrical connection with the patient interface 6000 when received by the charging dock 6044.

[0364] For example, the front strap 6304 may be located on the grooved surface of the charging dock 6044. The front strap 6304 may be positioned such that the battery dock 6328 of the front strap 6304 is located in close proximity to the grooved surface. In some embodiments, the inner surface of the front strap 6304 (i.e., the part that comes into contact with the patient) may include electrical terminals (not shown). The electrical terminals may provide an electrical connection to a battery 6030 connected to the battery dock 6328.

[0365] In some configurations, the charging dock 6044 itself may be a battery with stored charge. This allows the charger 6040 to be freely moved and placed in various locations in order to charge the battery 6030.

[0366] Alternatively or additionally, the charger 6040 may include a power cord (not shown) that can be connected to a wall outlet. The wall outlet may supply power to the charger 6040, and the charger 6040 may supply power to recharge the battery 6030.

[0367] In some configurations, the positioning and stabilizing structure 6300 may substantially maintain its three-dimensional shape when not in use (i.e., on the patient's head). For example, the rigidizer 6312 may maintain the front strap 6304 in a three-dimensional shape (e.g., similar to the shape of the patient's head). The charging dock 6044 may be formed to substantially the same height as the distance between the flow generator casing 6400 and the battery dock 6328. This may also be the distance between the patient's mouth and the top of the patient's head, measured upward along the sagittal plane. When connected to the charger 6040, the flow generator casing 6400 may come into contact with the charging base 6042 so that it is supported (e.g., not hanging on the surface). In addition, the front strap 6304 may be bundled or folded (e.g., as a result of the height of the charging dock 6044 being less than the distance between the flow generator casing 6400 and the battery dock 6328).

[0368] In other forms in which the front strap 6304 does not have a rigidizer 6312, the height of the charging dock 6044 may be the same as the height described above, so that the flow generator casing 6400 can still contact the charging base 6042. 5.3.10.4 Carry-on suitcase

[0369] Figure 26 shows a case 6050 for carrying a patient interface (for example, a patient interface 6000 is shown, but it may be inserted into the case 6050). As described above, the positioning and stabilizing structure 6300 may have a three-dimensional shape, for example, as a result of the rigidizer 6312 of the front strap 6304. The case 6050 may be large enough to accommodate the patient interface 6000 without substantially bending the front strap 6304. This may help maintain the lifespan of the positioning and stabilizing structure 6300. The back straps (e.g., upper back strap 6316 and lower back strap 6320) do not have to include rigidifying elements and may be bendable when inserted into the case 6050. 5.4 RPT Devices

[0370] An RPT device 4000 according to one aspect of this technology comprises mechanical, pneumatic, and / or electrical components and is configured to perform one or more algorithms 4300 (e.g., any of the methods described herein, either entirely or in part). The RPT device 4000 may be configured to generate an airflow for delivery to a patient's airway and may be configured, for example, to treat one or more respiratory conditions described elsewhere herein.

[0371] In one embodiment, the RPT device 4000 is constructed and positioned to deliver an airflow in the range of -20 L / min to +150 L / min while maintaining a positive pressure of at least 4 cmH2O, at least 10 cmH2O, or at least 20 cmH2O.

[0372] The RPT device may have an external housing 4010 formed in two parts, an upper part 4012 and a lower part 4014. Furthermore, the external housing 4010 may include one or more panels 4015. The RPT device 4000 includes a chassis 4016 that supports one or more internal components of the RPT device 4000. The RPT device 4000 may include a handle 4018.

[0373] The air path of the RPT device 4000 consists of one or more air path items, for example, an inlet air filter 4112, an inlet muffler 4122, a pressure generator 4140 (e.g., a blower 4142) capable of supplying air at positive pressure, an outlet muffler 4124, and one or more transducers 4270 (e.g., a pressure sensor 4272 and a flow sensor 4274).

[0374] One or more of the air passage items may be located within a removable, integrated structure called a pneumatic block 4020. The pneumatic block 4020 may be located within the external housing 4010. In one embodiment, the pneumatic block 4020 is supported by or formed as part of the chassis 4016.

[0375] The RPT device 4000 may include a power supply 4210, one or more input devices 4220, a central controller 4230, a therapy device controller 4240, a pressure generator 4140, one or more protection circuits 4250, memory 4260, a transducer 4270, a data communication interface 4280, and one or more output devices 4290. The electrical components 4200 may be mounted on a single printed circuit board assembly (PCBA) 4202. In an alternative configuration, the RPT device 4000 may include multiple PCBAs 4202. 5.4.1 Mechanical and pneumatic components of RPT devices

[0376] An RPT device may include one or more of the following components in a single unit. In one alternative configuration, one or more of the following components may be arranged as separate units. 5.4.1.1 Air filters (multiple filters allowed)

[0377] An RPT device according to one embodiment of this technology may include an air filter 4110 or a plurality of air filters 4110.

[0378] In one configuration, the inlet air filter 4112 is located upstream of the pressure generator 4140 at the beginning of the air pressure path.

[0379] In one configuration, the outlet air filter 4114, for example, an antimicrobial filter, is located between the outlet of the pneumatic block 4020 and the patient interface 3000. 5.4.1.2 Muffler (multiple mufflers are allowed)

[0380] An RPT device according to one embodiment of this technology may include a muffler 4120 or a plurality of mufflers 4120.

[0381] In one embodiment of this technology, the inlet muffler 4122 is located in the pneumatic path upstream of the pressure generator 4140.

[0382] In one embodiment of this technology, the outlet muffler 4124 is located within the pneumatic path between the pressure generator 4140 and the patient interface 3000. 5.4.1.3 Pressure Generator

[0383] In one embodiment of this technology, the pressure generator 4140 for generating a positive pressure airflow or supply is a controllable blower 4142. For example, the blower 4142 may include a brushless DC motor 4144 having one or more impellers. The impellers may be arranged in a spiral pattern. The blower may be capable of supplying air at a positive pressure ranging from about 4 cmH2O to about 20 cmH2O, or in other embodiments up to about 30 cmH2O, at a speed of, for example, up to about 120 liters / minute, when performing respiratory pressure therapy. The blower is described in any one of the following patents or patent applications, namely U.S. Patent No. 7,866,944, U.S. Patent No. 8,638,014, U.S. Patent No. 8,636,479, and PCT International Patent Application Publication No. 2013 / 020167, the entire literature of which is incorporated herein by reference.

[0384] The pressure generator 4140 can be under the control of the therapy device controller 4240.

[0385] In other forms, the pressure generator 4140 may be a piston-driven pump, a pressure regulator connected to a high-pressure source (e.g., a pressurized air reservoir), or a bellows. 5.4.1.4 Transducer(s)

[0386] The transducer may be located inside or outside the RPT device. An external transducer may be positioned on or form part of an air circuit, such as a patient interface. The external transducer may also be in the form of a non-contact sensor, such as a Doppler radar motion sensor, that transmits or transfers data to the RPT device.

[0387] In one embodiment of this technology, one or more sensors 4270 are positioned upstream and / or downstream of the pressure generator 4140. One or more transducers 4270 may be configured and positioned to generate signals representing airflow characteristics, such as flow velocity, pressure, or temperature at that point in the pneumatic path.

[0388] In one embodiment of this technology, one or more transducers 4270 may be located in close proximity to the patient interface 3000.

[0389] In one configuration, the signal from the converter 4270 may be filtered by low-pass filtering, high-pass filtering, or band-pass filtering, etc. 5.4.1.4.1 Flow Sensor

[0390] The flow sensor 4274 based on this technology may be based on a pressure difference transducer, such as the SENSIRION SDP600 series pressure difference transducer.

[0391] In one configuration, the signal representing the flow rate, generated by the flow sensor 4274, is received by the central controller 4230. 5.4.1.4.2 Pressure Sensor

[0392] The pressure sensor 4272 in this technology is positioned to communicate with both the pneumatic path and the fluid. A suitable example of a pressure sensor is the transducer from the HONEYWELL ASDX series. A suitable alternative pressure sensor is the NPA series transducer from GENERAL ELECTRIC.

[0393] In one configuration, the pressure signal generated by the pressure sensor 4272 and representing the pressure is received by the central controller 4230. 5.4.1.4.3 Motor Speed ​​Transducer

[0394] In one embodiment of this technology, the motor speed sensor 4276 is used to determine the rotational speed of the motor 4144 and / or the blower 4142. The motor speed signal from the motor speed transducer 4276 may be supplied to the therapy device controller 4240. The motor speed sensor 4276 may be a speed sensor such as a Hall effect sensor. 5.4.1.5 Anti-spillback valve

[0395] In one embodiment of this technology, the anti-spillback valve 4160 may be located between the humidifier 5000 and the pneumatic block 4020. The anti-spillback valve is constructed and positioned to reduce the risk of water flowing upstream from the humidifier 5000, for example, to the motor 4144. 5.4.2 Electrical Components of RPT Devices 5.4.2.1 Power supply

[0396] The power supply 4210 may be located inside or outside the external housing 4010 of the RPT device 4000.

[0397] In one embodiment of this technology, the power supply 4210 supplies power only to the RPT device 4000. In another embodiment of this technology, the power supply 4210 supplies power to both the RPT device 4000 and the humidifier 5000. 5.4.2.2 Input Devices

[0398] In one embodiment of this technology, the RPT device 4000 includes one or more input devices 4220 in the form of buttons, switches, or turntables that enable a person to interact with the device. The buttons, switches, or dials may be physical devices or software devices accessible via a touchscreen. In one embodiment, the buttons, switches, or dials may be physically connected to an external housing 4010, or in another embodiment, they may be wirelessly connected to a receiver electrically connected to a central controller 4230.

[0399] In one embodiment, the input device 4220 may be configured and positioned to allow a person to select a value and / or a menu option. 5.4.2.3 Central Controller

[0400] In one embodiment of this technology, the central controller 4230 is one or more processors suitable for controlling the RPT device 4000.

[0401] Suitable processors may include x86 Intel processors, processors based on ARM® Cortex®-M processors from ARM Holdings (e.g., STM32 series microphone controllers from ST MICROELECTRONICS). In certain alternative forms of this technology, 32-bit RISC CPUs such as ST MICROELECTRONICS' STR9 series microphone controllers manufactured by TEXAS INSTRUMENTS, or 16-bit RISC CPUs such as processors from the MSP430 family of microphone controllers may also be suitable.

[0402] In one embodiment of this technology, the central controller 4230 is a dedicated electronic circuit.

[0403] In one embodiment, the central controller 4230 is an application-specific integrated circuit. In another embodiment, the central controller 4230 includes discrete electronic components.

[0404] The central controller 4230 may be configured to receive input signals(s) from one or more transducers 4270, one or more input devices 4220, and a humidifier 5000.

[0405] The central controller 4230 may be configured to provide output signals to one or more of the output devices 4290, the therapy device controller 4240, the data communication interface 4280, and the humidifier 5000.

[0406] In some embodiments of this technology, the central controller 4230 is configured to implement one or more algorithms 4300, which can be implemented by processor control instructions expressed as computer programs stored in a non-temporary computer-readable storage medium (e.g., memory 4260), for example, one or more methodologies described herein. In some embodiments of this technology, the central controller 4230 may be integrated with the RPT device 4000. However, in some embodiments of this technology, some methodologies may be performed by a remotely located device. For example, a remote device can analyze stored data, such as data from any of the sensors described herein, to determine ventilator control settings or detect respiratory-related events. 5.4.2.4 Clock

[0407] The RPT device 4000 may include a clock 4232 connected to the central controller 4230. 5.4.2.5 Therapeutic device controllers

[0408] In one embodiment of this technology, the therapy device controller 4240 is a therapy control module 4330 that forms part of an algorithm 4300 executed by the central controller 4230.

[0409] In one embodiment of this technology, the therapy device controller 4240 is a dedicated motor control integrated circuit. For example, in one embodiment, an ONSEMI MC33035 brushless DC motor controller is used. 5.4.2.6 Protection circuit

[0410] One or more protection circuits 4250 in this technology may include electrical protection circuits, temperature and / or pressure safety circuits. 5.4.2.7 Memory

[0411] According to one embodiment of this technology, the RPT device 4000 includes a memory 4260, for example, a non-volatile memory. In some embodiments, the memory 4260 may include a battery-powered static RAM. In some embodiments, the memory 4260 may include a volatile RAM.

[0412] Memory 4260 may be located on PCBA 4202. Memory 4260 may take the form of EEPROM or NAND flash.

[0413] Additionally or alternatively, the RPT device 4000 includes, in the form of, removable memory 4260 such as a memory card manufactured in accordance with the Secure Digital (SD) standard.

[0414] In one embodiment of this technology, the memory 4260 functions as a non-temporary computer-readable storage medium that stores computer program instructions representing one or more methodologies described herein, for example, one or more algorithms 4300. 5.4.2.8 Data Communication System

[0415] In one embodiment of this technology (see, for example, Figure 4C), a data communication interface 4280 is provided and connected to a central controller 4230. The data communication interface 4280 may be connectable to a remote external communication network 4282 and / or a local external communication network 4284. The remote external communication network 4282 may be connectable to a remote external device 4286. The local external communication network 4284 may be connectable to a local external device 4288.

[0416] In one embodiment, the data communication interface 4280 is part of the central controller 4230. In another embodiment, the data communication interface 4280 is separate from the central controller 4230 and may include an integrated circuit or processor.

[0417] In one embodiment, the remote external communication network 4282 is the Internet. The data communication interface 4280 may connect to the Internet using wired communication (e.g., via Ethernet or optical fiber) or wireless protocols (e.g., CDMA, GSM, LTE).

[0418] In one configuration, the local external communication network 4284 uses one or more communication standards (e.g., Bluetooth or consumer infrared protocol).

[0419] In one embodiment, the remote external device 4286 is one or more computers, for example, a cluster of networked computers. In another embodiment, the remote external device 4286 may be a virtual computer rather than a physical computer. In either case, such a remote external device 4286 may be accessible to appropriately authorized persons, such as clinicians.

[0420] The local external device 4288 may be a personal computer, mobile phone, tablet, or remote control. 5.4.2.9 Optional Output Devices Including Displays and Alarms

[0421] As shown in Figure 4C, the output device 4290 according to this technology may take the form of one or more of the visual, audio, and haptic units. The visual display may be a liquid crystal display (LCD) or a light-emitting diode (LED) display. 5.4.2.9.1 Display Driver

[0422] As shown in Figure 4C, the display driver 4292 receives characters, symbols, or images intended to be displayed on the display 4294 as input and converts them into commands that cause the display 4294 to display those characters, symbols, or images. 5.4.2.9.2 Display

[0423] As shown in Figure 4C, the display 4294 is configured to visually display characters, symbols, or images in response to commands received from the display driver 4292. For example, the display 4294 may be an 8-segment display, in which case the display driver 4292 translates each character or symbol (e.g., the digit "0") into eight logical signals indicating whether each of the eight segments should be activated to display a particular character or symbol. 5.4.3 RPT Device Algorithm

[0424] As described above, in some forms of this technology (see, for example, Figure 4D), the central controller 4230 may be configured to implement one or more algorithms 4300, which are represented as computer programs stored in a non-temporary computer-readable storage medium such as memory 4260. The algorithms 4300 are grouped into groups generally called modules.

[0425] In other embodiments of this technology, part or all of the algorithm 4300 may be implemented by a controller of an external device (e.g., a local external device 4288 or a remote external device 4286). In this embodiment, input signals and / or intermediate algorithm output data necessary to represent part of the algorithm 4300 executed on the external device may be transmitted to the external device via a local external communication network 4284 or a remote external communication network 4282. In such an embodiment, part of the algorithm 4300 executed on the external device may be represented as a computer program stored on a non-temporary computer-readable storage medium that can access the controller of the external device, including processor control instructions executed by one or more processors. Such a program configures the controller of the external device to execute part of the algorithm 4300.

[0426] In this configuration, therapeutic parameters generated by an external device via the therapeutic engine module 4320 (if this configuration forms part of an algorithm 4300 executed by the external device) can be transmitted to the central controller 4230 and sent to the therapeutic control module 4330. 5.4.3.1 Preprocessing Module

[0427] A preprocessing module 4310 according to one embodiment of this technology (see, for example, Figure 4D) receives a signal from a transducer 4270, such as a flow sensor 4274 or a pressure sensor 4272, as input and performs one or more processing steps to calculate one or more output values ​​to be used as input to another module, such as a therapy engine module 4320.

[0428] In one embodiment of this technology, the output values ​​include interface pressure Pm, ventilation flow rate Qv, respiratory flow rate Qr, and leakage flow rate Ql.

[0429] In various forms of this technology, the preprocessing module 4310 includes one or more algorithms from among the interface pressure estimation algorithm 4312, the ventilation flow rate estimation algorithm 4314, the leakage flow rate estimation algorithm 4316, and the respiratory flow rate estimation algorithm 4318. 5.4.3.1.1 Interface Pressure Estimation

[0430] In one embodiment of this technology, the interface pressure estimation algorithm 4312 receives as input a signal from a pressure sensor 4272 indicating the pressure in the pneumatic path near the outlet of the pneumatic block (device pressure Pd) and a signal from a flow sensor 4274 indicating the flow rate of the airflow exiting the RPT device 4000 (device flow rate Qd). The device flow rate Qd can be used as the total flow rate Qt in the absence of supplemental gas 4180. The interface pressure estimation algorithm 4312 estimates the pressure drop ΔP through the air circuit 4170. The dependence of the pressure drop ΔP on the total flow rate Qt can be modeled for a particular air circuit 4170 by the pressure drop characteristic ΔP(Q). The interface pressure estimation algorithm 4312 then provides the estimated pressure Pm as output to the patient interface 3000. The pressure Pm in the patient interface 3000 can be estimated as the device pressure Pd minus the air circuit pressure drop ΔP. 5.4.3.1.2 Ventilation flow rate estimation

[0431] In one embodiment of this technology, the ventilation flow rate estimation algorithm 4314 receives the estimated pressure Pm at the patient interface 3000 as input from the interface pressure estimation algorithm 4312, and estimates the ventilation flow rate Qv from the ventilation unit 3400 at the patient interface 3000. The dependence of the ventilation flow rate Qv on the interface pressure Pm at a particular ventilation opening 3400 in use can be modeled by the ventilation characteristic Qv(Pm). 5.4.3.1.3 Leakage Flow Rate Estimation

[0432] In one embodiment of this technology, the leak flow rate estimation algorithm 4316 takes a total flow rate Qt and a ventilation flow rate Qv as inputs and provides an estimate of the leak flow rate Ql as an output. In one embodiment, the leak flow rate estimation algorithm estimates the leak flow rate Ql by calculating the average value of the difference between the total flow rate Qt and the ventilation flow rate Qv over a time period long enough to include several respiratory cycles (e.g., 10 s).

[0433] In one embodiment, the leak flow rate estimation algorithm 4316 takes the total flow rate Qt, ventilatory flow rate Qv, and estimated pressure Pm at the patient interface 3000 as inputs and supplies the leak flow rate Ql as an output, by calculating the leak conductance and determining the leak flow rate Ql as a function of the leak conductance and pressure Pm. The leak conductance is calculated as the quotient of the low-pass filtered unaventilatory flow rate equal to the difference between the total flow rate Qt and the ventilatory flow rate Qv, and the low-pass filtered square root of the pressure Pm, where the low-pass filtered time constant has a value long enough to include several respiratory cycles, for example, about 10 seconds. The leak flow rate Ql may also be estimated as a function of the product of the leak conductance and pressure Pm. 5.4.3.1.4 Respiratory flow estimation

[0434] In one embodiment of this technology, the respiratory flow rate estimation algorithm 4318 takes total flow rate QT, ventilatory flow rate Qv, and leakage flow rate Ql as inputs and estimates the air-breathing flow rate Qr for the patient by subtracting the ventilatory flow rate Qv and leakage flow rate Ql from the total flow rate Qt. 5.4.3.2 Treatment Engine Module

[0435] In one embodiment of this technology, the therapy engine module 4320 receives one or more of the pressure Pm and the air breathing flow rate Qr to the patient as inputs within the patient interface 3000, and provides one or more therapy parameters as outputs.

[0436] In one form of this technology, the therapeutic parameter is the therapeutic pressure Pt.

[0437] In one embodiment of this technology, the therapeutic parameters are one or more of the following: pressure fluctuation amplitude, base pressure, and target ventilation.

[0438] In various forms, the therapeutic engine module 4320 includes one or more algorithms from among the following: phase determination algorithm 4321, waveform determination algorithm 4322, ventilation determination algorithm 4323, inspiratory flow limitation determination algorithm 4324, apnea / hypopnea determination algorithm 4325, snoring determination algorithm 4326, airway patency determination algorithm 4327, target ventilation determination algorithm 4328, and therapeutic parameter determination algorithm 4329. 5.4.3.2.1 Phase determination

[0439] In one embodiment of this technology, the RPT device 4000 does not determine the phase.

[0440] In one embodiment of this technology, the phase determination algorithm 4321 receives a signal indicating the respiratory flow rate Qr as input and provides the phase Φ of the current respiratory cycle of patient 1000 as output.

[0441] In some forms, this is called discrete phase determination, where the phase output Φ is a discrete variable. One implementation of discrete phase determination provides a binary phase output Φ with values ​​for inhalation or exhalation, for example, 0 and 0.5 rotations, respectively, when the start of spontaneous inhalation and exhalation are detected, respectively. The “trigger” and “loop” RPT device 4000 can efficiently perform discrete phase determination because the trigger and loop points are the moments when the phase changes from exhalation to inhalation and from inhalation to exhalation, respectively. In one implementation of binary phase determination, if the respiratory flow rate Qr is above a positive threshold, the phase output Φ is determined to a discrete value of 0 (thus “triggering” the RPT device 4000), and if the respiratory flow rate Qr is below a negative threshold, the phase output is determined to a discrete value of 0.5 rotations (thus “cycled” the RPT device 4000). The inspiratory time Ti and expiratory time Te can be estimated as typical values ​​for many respiratory cycles, where the time spent in stage Φ is equal to 0 (representing inspiration) and 0.5 (representing expiration), respectively.

[0442] Another implementation of discrete phase determination provides a tri-phase output Φ having one of the following values: inhalation, pause during inhalation, or exhalation.

[0443] In another form called continuous phase determination, the phase output Φ is a continuous variable, such as changing from 0 to 1 revolution or from 0 to 2π radians. The RPT device 4000, which performs continuous phase determination, can be triggered and looped when the continuous phase reaches 0 revolutions and 0.5 revolutions, respectively. In one implementation of continuous phase determination, the continuous value of phase Φ is determined using fuzzy logic analysis of the respiratory flow rate Qr. The continuous phase value determined in this implementation is generally called the "fuzzy phase". In one implementation of the fuzzy phase determination algorithm 4321, the following rules are applied to the respiratory flow rate Qr.

[0444] 1. If Qr is zero and increases rapidly, then Φ is considered to have 0 rotations.

[0445] 2. If Qr is large and stable and positive, then Φ should be 0.25 rotations.

[0446] 3. If Qr is zero and rapidly decreasing, then Φ should be 0.5 rotations.

[0447] 4. If Qr is stable and significantly negative, then Φ should be 0.75 rotations.

[0448] 5. If Qr is stable at zero and the absolute value of Qr after 5-second low-pass filtering of the respiratory flow rate is large, then Φ should be 0.9 rotations.

[0449] 6. If Qr is positive and the phase is exhalation, then Φ is set to 0 rotations.

[0450] 7. If Qr is negative and the phase is intake, then Φ shall be 0.5 rotations.

[0451] 8. If the absolute value of Qr after 5 seconds of low-pass filtering of respiratory flow is large, Φ increases at a steady rate equal to the patient's respiratory rate and is low-pass filtered with a time constant of 20 seconds.

[0452] The output of each rule can be represented as a vector having a phase, which is the result of the rule, and a magnitude, which is the degree of ambiguity to which the rule is true. The degree of blurring, such as when the respiratory flow rate is "high" or "stable," is determined by an appropriate membership function. The results of the rules are represented as vectors and are combined by several functions, such as the centroid. In this combination, the weights of the rules may be equal or different.

[0453] In another implementation of continuous phase determination, the phase Φ is first discretely estimated based on the respiratory flow rate Qr from the inspiratory time Ti and expiratory time Te, as described above. The continuous phase Φ at any given time can be obtained by adding 0.5 rotations to either half the proportion of the inspiratory time Ti elapsed since the previous trigger time, or half the proportion of the expiratory time Te elapsed since the previous cycle time (whichever time is closer). 5.4.3.2.2 Waveform Determination

[0454] In one embodiment of this technology, the therapy parameter determination algorithm 4329 provides a nearly constant therapeutic pressure throughout the patient's entire respiratory cycle.

[0455] In another embodiment of this technology, the therapy control module 4330 controls the pressure generator 4140 to provide a therapeutic pressure Pt that changes as a function of the phase Φ of the patient's respiratory cycle, according to a waveform template Π(Φ).

[0456] In one embodiment of this technology, the waveform determination algorithm 4322 provides a waveform template Π(Φ) having a value within the domain range [0,1] of the phase value Φ provided by the phase determination algorithm 4321 and used by the therapy parameter determination algorithm 4329.

[0457] In one form, applicable to discrete or continuous phases, the waveform template Π(Φ) is a square wave template where the value is 1 for phase values ​​less than 0.5 turns and 0 for phase values ​​greater than or equal to 0.5 turns. In the form suitable for continuous phases, the waveform template Π(Φ) has two smoothly curved portions: a smoothly curved portion (e.g., a rising cosine) where the phase value rises from 0 to 1 up to 0.5 turns, and a smooth bend (e.g., exponentially for phase values ​​greater than 0.5 turns) where the phase value decays from 1 to 0. In the form suitable for continuous phases, the waveform template Π(Φ) is based on a square wave, but the phase value rises smoothly from 0 to less than 0.5 turns for a "rise time," and then falls smoothly from 1 to 0 during a "fall time" after 0.5 turns, with the "fall time" being less than 0.5 turns.

[0458] In some forms of this technology, the waveform determination algorithm 4322 selects a waveform template Π(Φ) from a waveform template library according to the settings of the RPT device. Each waveform template Π(Φ) in the library can be provided as a lookup table of values ​​Π for a phase value Φ. In other forms, the waveform determination algorithm 4322 uses a predetermined functional form (which may be parameterized by one or more parameters (e.g., time constants of the exponential curve portion)) to calculate the waveform template Π(Φ) "dynamically". The parameters of the functional form may be predetermined or may depend on the current state of patient 1000.

[0459] In some forms of this technology, it is applied to discrete binary phases of inhalation (Φ=0 rotations) or exhalation (Φ=0.5 rotations), and the waveform determination algorithm 4322 calculates the waveform template Π "dynamic" as a function of discrete phase Φ measured since the most recent trigger moment and time t. In one such form, the waveform determination algorithm 4322 calculates the waveform template Π(Φ,t) as two parts (inhalation and exhalation), as follows:

[0460]

number

[0461] Here, Π i (t), and Π e (t) is the expiratory / inspiratory portion of the waveform template Π(Φ,t). In one form, the inspiratory portion Π of the waveform template i (t) is a smooth rise from 0 to 1, parameterized by the rise time, and represents the exhalation portion Π of the waveform template. e (t) is a smooth fall from 1 to 0, parameterized by the fall time. 5.4.3.2.3 Ventilation Decision

[0462] In one aspect of the present technology, the ventilation determination algorithm 4323 receives the respiratory flow rate Qr as an input and determines a measurement value indicating the current patient ventilation vent.

[0463] In some implementations, the ventilation determination algorithm 4323 determines a measurement value of the ventilation volume, which is an estimated value of the actual patient's ventilation volume. In such an implementation, half of the absolute value of the respiratory flow rate Qr is taken, or it is filtered through a low-pass filter such as a second-order Bezier low-pass filter having a corner frequency of 0.11 Hz.

[0464] In other implementations, the ventilation determination algorithm 4323 determines a measurement value of the ventilation vent that is substantially proportional to the actual patient ventilation. In such an implementation, the peak respiratory flow rate Qpeak of the estimated cycle inhalation interval is realized. By this procedure and many other procedures involving sampling of the respiratory flow rate Qr, a measured value that is approximately proportional to the ventilation can be obtained on the condition that the shape of the flow rate waveform does not change much (here, when the respiratory flow rate waveforms normalized by time and amplitude are similar, the shapes of the two breaths are considered to be similar). Simple examples include the median of the positive respiratory flow rate, the median of the absolute value of the respiratory flow rate, and the standard deviation of the flow rate. Any linear combination of any order statistics of the absolute value of the respiratory flow rate using positive coefficients, or even those using both positive and negative coefficients, is approximately proportional to the ventilation volume. Another example is the average value of the respiratory flow rate at the K-th ratio (time) in the middle of the inhalation part, where 0 < K < 1. When the flow rate shape does not change, there are arbitrarily multiple measured values proportional to the completeness of the ventilation. 5.4.3.2.4 Inspiratory Flow Limitation Determination

[0465] In one aspect of the present technology, the central controller 4230 executes an inspiratory flow limitation determination algorithm 4324 to determine the degree of the inspiratory flow limitation.

[0466] In one aspect, the inspiratory flow limitation determination algorithm 4324 receives the inspiratory flow rate signal Qr as an input and provides, as an output, a measure of the degree to which the inspiratory part of the breath indicates an inspiratory flow limitation.

[0467] In one embodiment of this technology, the inspiratory portion of each breath is identified by a zero-crossing detector. Along the inspiratory flow-time curve of each breath, an interpolator interpolates multiple equally spaced points (e.g., 65) representing each time point are interpolated. The curve described by the points is then scaled scalarly to have a uniform length (duration / cycle) and uniform area to eliminate the effects of changes in respiratory rate and depth. The scaled breath is then compared in a comparator to a pre-stored template representing a normal open breath, similar to the inspiratory portion of the breath shown in Figure 6A. Any breath that deviates from this template by a predetermined threshold (usually 1 proportional unit) at any point during inspiration, such as a cough, sigh, swallow, or belch, as determined by the test element, is rejected. For data that is not rejected, the central controller 4230 calculates the moving average of the first such scaled points of the first few inspiratory vents. For such second points, this is repeated for the same inspiratory event, and so on. Therefore, for example, 65 scaled data points are generated by the central controller 4230, representing the moving average of the first few intake vents (e.g., three vents). The moving average of the continuously updated values ​​of (e.g., 65) points is hereafter referred to as the "scaled flow rate" and defined as Qs(t). Alternatively, a single intake event may be used instead of the moving average.

[0468] From the scaling flow rate, two shape factors associated with the determination of partial occlusion can be calculated.

[0469] The shape factor of 1 is the ratio of the average of the intermediate (e.g., 32) scaling flow points to the average of the total (e.g., 65) scaling flow points. A ratio greater than 1 indicates normal respiration. A ratio less than or equal to 1 indicates respiratory obstruction. A ratio of approximately 1.17 is used as a threshold between partial and acrobatic respiration and is equivalent to the degree of obstruction that allows for adequate oxygenation in a typical patient.

[0470] The shape factor 2 is calculated as the mean square deviation from the unit scaling flow rate and is defined as exceeding the median value (e.g., 32). A mean square deviation of approximately 0.2 units is considered normal. A mean square deviation of zero is considered to represent a completely flow-restricted respiration. The closer the mean square deviation is to zero, the more flow-restricted the respiration is.

[0471] Shape factors 1 and 2 can be used as alternatives or in combination. In other forms of this technique, the number of sampling points, breathing points, and intermediate points may differ from those described above. Also, the threshold may differ from the threshold described. 5.4.3.2.5 Determination of Apnea and Hypopnea

[0472] In one embodiment of this technology, the central controller 4230 executes an apnea / hypopnea determination algorithm 4325 to determine the presence of apnea and / or hypopnea.

[0473] In one form, the apnea / hypopnea determination algorithm 4325 receives a respiratory flow signal Qr as input and provides a flag as output indicating that apnea or hypopnea has been detected.

[0474] In one form, apnea can be detected when the respiratory flow rate (Qr) function falls below a flow threshold over a predetermined period of time. This function can be used to determine the peak flow rate, the relative short-term mean flow rate, or the midpoint flow rate between the relative short-term mean and peak flow rates, such as the RMS flow rate. The flow threshold may be a relatively long-term measure of flow rate.

[0475] In one embodiment, hypopnea is detected when the function of respiratory flow rate Qr falls below a second flow threshold over a predetermined period of time. This function can determine the peak flow rate, the relative short-term mean flow rate, or the midpoint flow rate between the relative short-term mean and peak flow rates, such as the RMS flow rate. The second flow threshold may be a relatively long-term measure of flow rate. The second flow threshold is greater than the flow threshold used to detect apnea. 5.4.3.2.6 Snoring confirmed

[0476] In one embodiment of this technology, the central controller 4230 executes one or more snoring determination algorithms 4326 to determine the degree of snoring.

[0477] In one form, the snoring determination algorithm 4326 takes a respiratory flow signal Qr as input and provides a measure of the degree of snoring as output.

[0478] The snoring determination algorithm 4326 may include a step of determining the intensity of the flow signal in the range of 30 to 300 Hz. Furthermore, the snoring determination algorithm 4326 may include a step of filtering the respiratory flow signal Qr to reduce background noise, such as the sound of airflow in the system from a blower. 5.4.3.2.7 Determining Airway Patency

[0479] In one embodiment of this technology, the central controller 4230 executes one or more airway patency determination algorithms 4327 to determine the degree of airway patency.

[0480] In one configuration, the airway patency determination algorithm 4327 receives a respiratory flow signal Qr as input and determines the power of the signal in the frequency ranges of approximately 0.75 Hz and 3 Hz. The appearance of a peak within this frequency range indicates that the airway is open. The absence of a peak is thought to indicate airway closure.

[0481] In one configuration, the frequency range for determining the peak is the frequency of small forced oscillations at the therapeutic pressure Pt. In one implementation configuration, the frequency of forced oscillation is 2 Hz, and the amplitude is approximately 1 cmH2O.

[0482] In one form, the airway patency determination algorithm 4327 receives a respiratory flow signal Qr as input and determines the presence or absence of a cardiogenic signal. The absence of a cardiogenic signal is considered a sign of airway atresia. 5.4.3.2.8 Determining the Target Ventilation

[0483] In one embodiment of this technology, the central controller 4230 takes the current ventilation measurement value vent as input and executes one or more target ventilation determination algorithms 4328 to determine a target value Vtgt for the ventilation measurement.

[0484] In some forms of this technology, the target ventilation determination algorithm 4328 is absent, and the target value Vtgt is predetermined, for example, by hardcoding during the configuration of the RPT device 4000, or by manual input via the input device 4220.

[0485] In other forms of this technology, such as adaptive servo ventilation (ASV), the target ventilation determination algorithm 4328 calculates the target value Vtgt from a value Vtyp that represents the patient's typical recent ventilation.

[0486] In some forms of adaptive servo ventilation, the target ventilation Vtgt is calculated as a high percentage of the typical recent ventilation Vtyp, but smaller. Such high percentages may range from (80%, 100%), (85%, 95%), to (87%, 92%).

[0487] In other forms of adaptive servo ventilation, the target ventilation Vtgt is calculated as a unit multiple that is slightly larger than the typical recent ventilation Vtyp.

[0488] A typical recent ventilation (Vtyp) is a value that represents the tendency of the current ventilation distribution at multiple temporal moments on a given time scale to converge; i.e., it is a measure of the current ventilation's tendency to concentrate in the recent past. In the implementation of the target ventilation determination algorithm 4328, the recent history is on the order of minutes, but in any case it must be longer than the time scale of the Cheyne-Stokes upper and lower quarter cycles. The target ventilation determination algorithm 4328 can use any of various known concentration tendency measurements to determine a typical recent ventilation (Vtyp) from the current ventilation measurement (vent). One such measurement is the output of a low-pass filter on the current ventilation measurement (vent), with a time constant equal to 100 seconds. 5.4.3.2.9 Determination of treatment parameters

[0489] In some forms of this technology, the central controller 4230 executes one or more treatment parameter determination algorithms 4329 to determine one or more treatment parameters using values ​​returned by one or more other algorithms in the treatment engine module 4320.

[0490] In one embodiment of this technology, the therapeutic parameter is the instantaneous therapeutic pressure Pt. In one implementation of this embodiment, the therapeutic parameter determination algorithm 4329 determines the therapeutic pressure Pt using an equation.

[0491]

number

[0492] Here, A is the amplitude. • Π(Φ,t) is the current phase value Φ and the waveform template value (in the range of 0 to 1) at time t. P0 is the base pressure.

[0493] If the waveform determination algorithm 4322 provides a waveform template Π(Φ,t) as a lookup table of values ​​Π indexed by phase Φ, the therapy parameter determination algorithm 4329 applies equation (1) by locating the lookup table entry closest to the current value Φ of phase returned by the phase determination algorithm 4321, or by interpolating between two entries that cross the current value Φ of phase.

[0494] Depending on the selected respiratory pressure therapy mode, the therapy parameter determination algorithm 4329 can set the values ​​of amplitude A and base pressure P0 as follows. 5.4.3.3 Treatment control module

[0495] A therapy control module 4330 according to one aspect of this technology receives therapy parameters as input from the therapy parameter determination algorithm 4329 of the therapy engine module 4320, and controls the pressure generator 4140 to deliver a gas flow according to the therapy parameters.

[0496] In one embodiment of this technology, the therapeutic parameter is the therapeutic pressure Pt, and the therapeutic control module 4330 controls the pressure generator 4140 so that the interface pressure Pm at the patient interface 3000 is equal to the therapeutic pressure Pt. 5.4.3.4 Detection of Fault Conditions

[0497] In one embodiment of this technology, the central controller 4230 performs one or more methods 4340 for detecting fault conditions. Fault conditions detected by one or more methods 4340 are • Power off (power off or power off insufficient) • Sensor failure detection • Inability to detect the presence of a component. • Operating parameters outside the recommended range (pressure, flow rate, temperature, PaO2, etc.) • Test alarms cannot generate detectable alarm signals. When a fault condition is detected, the corresponding algorithm 4340 notifies of the presence of the fault by one or more of the following signals:

[0498] • Activation of audio, visual, and / or dynamic (such as vibration) alarms • Sending messages to external devices • Event logging 5.4.4 Built-in flow generator

[0499] As shown in Figures 27 to 31, the RPT device 6500 may be located within the flow generator casing 6400 of the patient interface 6000 (or either of the patient interfaces). For example, the RPT device 6500 may be located or enclosed within a cavity 6408 formed between the front case 6404 and the rear case 6406. The front case 6404 and the rear case 6406 may be formed from rigid or semi-rigid materials to protect the components housed within the cavity 6408.

[0500] In some embodiments, the RPT device 6500 may include a blower 6502. The blower 6502 may be substantially cylindrical in shape and positioned laterally within the cavity 6408.

[0501] In some forms, the RPT device 6500 may include a suspension 6504. The suspension 6504 may receive and support a blower 6502 within a cavity 6408.

[0502] As shown in Figure 31, the suspension 6504 may have at least one opening, such as two openings corresponding to the intake ports at the ends of the motor 6502, as shown in Figure 48. As shown in Figure 48, the motor 6502 may have at least one pair of impellers 6550 connected to a common shaft and configured to pressurize breathable air within a therapeutic range. The impellers are arranged in series, and their combined flow is released at one or more central outlets near the center of the motor 6502.

[0503] Returning to Figure 31, the suspension 6504 may be formed as a body with a substantially cylindrical shape (similar to, for example, the blower 6502), and may include at least a first opening 6506 along the longitudinal direction of the suspension 6504. Although only one opening is shown in Figure 31, a second opening (for the opposing impeller on that side) may be included at the other end of the suspension 6504. The first openings 6506 may be sized to accommodate the blower 6502, and each first opening may be sized to allow intake air from the surroundings to flow into its respective impeller.

[0504] The suspension 6504 may also include a second opening 6508 extending tangentially from the cylindrical surface of the suspension 6504. The second opening 6508 may be in fluid communication with the first opening 6506. During use, the airflow generated by the blower 6502 and output from at least one central outlet of the blower 6502 may be forced through the second opening 6504 toward the plenum chamber 6200.

[0505] In some configurations, the manifold 6510 may be connected to the suspension 6504 near the second opening 6508. For example, Figures 28 and 29 show the manifold 6510 connected directly to the suspension 6504 at the second opening 6508 and extending away from the cylindrical body of the suspension 6504.

[0506] As shown in Figure 29, the manifold 6510 may be hollow and may form an air channel together with the suspension 6504 to help transport pressurized air from the blower 6502 to the plenum chamber 6200. The manifold 6510 may include a first opening 6512 that is directly connected to a second opening 6508 of the suspension 6504. The manifold 6510 may have a second opening 6514 at the end opposite to the first opening 6512. Thus, the airflow may flow through the manifold 6510, enter through the first opening 6512, and exit through the second opening 6514.

[0507] In some embodiments, the first opening 6512 and the second opening 6514 may be oriented substantially perpendicular to each other. Thus, the manifold 6510 may change the direction of the air channel. For example, the air channel may move upward through the first opening 6512 in Figure 29 before moving backward through the second opening 6514 (for example, to the right as shown in Figure 29).

[0508] In some configurations, the expiratory-actuated valve (EAV) 6516 may be connected to the manifold 6510. For example, the EAV 6516 may be connected adjacent to the second opening 6514 of the manifold 6510. The EAV 6516 will be described in more detail below. However, the EAV 6516 may include at least one air channel so that the pressurized air exiting the second opening 6514 of the manifold 6510 is still directed to the plenum chamber 6200.

[0509] As shown in Figure 29, the EAV 6516 may be at least partially located within the inlet 6518 of the rear case 6468, for example, in the form of an inlet tube. The plenum chamber 6200 may be connected to the rear case 6406, and the inlet 6518 may extend into the plenum chamber 6200 so that the airflow passing through the inlet 6518 enters the plenum chamber 6200. For this purpose, an air channel may be provided for supplying pressurized air from the blower 6502 to the plenum chamber 6200.

[0510] As shown in Figure 31, the rear case 6406 may include a central groove or recess 6410 which is part of the cavity 6408 when the front case 6404 is connected. The central groove or recess 6410 may be semi-cylindrical in shape and may be configured to receive the blower 6502 and suspension 6504. The plenum chamber 6200 includes a front surface with a recessed portion that receives the convex outer portion of the casing or rear case that houses the blower, as shown in Figures 29 and 31. The casing, for example the rear case 6408, has, for example, a slightly elliptical inlet tube to match the shape of the valve shown in Figures 44-47, located above the convex outer portion of the casing or rear case, and the plenum chamber includes an inlet opening which may be provided in a more rigid portion of the seal-forming portion.

[0511] In some configurations, the central groove or recess 6410 may be substantially straight, while the rear case 6406 may be curved as described above. One or more mufflers 6412 may be connected to the rear case 6406 inside the cavity 6408 and outside the central groove 6410. In other words, the mufflers 6412 may be located at one or both ends of the blower 6502. Thus, the mufflers 6512 may help reduce the noise output of the blower 6502. This may be useful because the blower 6502 is located close to the patient's face and may cause noise-induced sleep disturbances.

[0512] Returning to Figures 27 and 29, the casing, for example, the rear case and / or front case 6404, may include an outlet vent 6414. In another example, the rear case 6406 may have an outlet vent 6414. The outlet vent 6414 allows exhaled air to be exhausted to the surroundings.

[0513] In the illustrated example (see, for example, Figure 29), the rear case 6406 may include an exhaust channel 6416. The EAV 6516 may be smaller than the inlet 6518 so that airflow can pass around the outside of the EAV 6516. The exhausted air flowing around the outside of the EAV 6516 (e.g., air leaving the plenum chamber 6200) may be directed by the EAV 6516 into the exhaust channel 6416 and pass through the outlet vent 6414. 5.4.4.1 Blower

[0514] The interior of the blower 6502 may be shown as in Figure 48. The blower 6502 may include at least one impeller 6550 (see, for example, Figure 49), for example, at least one pair of opposing impellers arranged parallel to each other within the blower housing 6552 and mounted on a common shaft. For example, the illustrated blower 6502 may include at least one or two pairs (four impellers) 6550, for example, a first pair of impellers and / or a second pair of impellers, on both sides of the magnet 6554 and winding 6556, and one on each side of the magnet.

[0515] As shown in Figures 50 and 51, alternative versions of impeller 6550-1 are presented. Impeller 6550-1 may be a double-sided impeller and may achieve the same pressure as impeller 6550 (e.g., Figure 49) in a smaller space. This may be beneficial for maximizing the limited space within the flow generator casing 6400.

[0516] In some configurations, the elastomer bearing 6558 may be coupled between a common shaft to which the impeller is mounted and the impeller 6550-1. The elastomer bearing 6558 may limit vibrations of the blower 6502.

[0517] In some forms, the blower may be similar to the blowers described in U.S. Patent Applications No. 16 / 320,565 and No. 17 / 602,552, both of which are incorporated herein by reference. 5.5 Air Circuit

[0518] An air circuit 4170 according to one aspect of this technology is a conduit or tube constructed and positioned to allow airflow to move between two components (e.g., an RPT device 4000 and a patient interface 3000) during use.

[0519] In detail, the air circuit 4170 may be fluidly connected to the outlet and patient interface of the pneumatic block 4020. The air circuit may also be called an air delivery tube. In some cases, there may be separate limbs of the circuit for inhalation and exhalation. In other cases, a single limb is used.

[0520] In some embodiments, the air circuit 4170 may include one or more heating elements configured to heat the air in the air circuit (for example, to maintain or raise the air temperature). The heating elements may take the form of a heating wire circuit and may include one or more transducers (e.g., temperature sensors). In one embodiment, the heating wire circuit may be helically wound around the axis of the air circuit 4170. The heating elements may communicate with a controller such as a central controller 4230. One embodiment of the air circuit 4170 including a heating wire circuit is described in U.S. Patent Application No. 8,733,349, which is incorporated herein by reference in its entirety. 5.5.1 Valve Assembly

[0521] As described above, the patient interface 6000 (or any of the described patient interfaces) may include an EAV 6516. The EAV 6516 may control the airflow through the patient interface. The EAV 6516 is described below, but other types of valves may be substituted without departing from the scope of the embodiment.

[0522] As shown in Figure 32, the EAV 6516 may have a disc-like shape. The EAV 6516 may include a retaining flange 6520. The retaining flange 6520 forms the outer circumference of the EAV 6516 and may help to position and / or hold the EAV 6516 in a desired position.

[0523] In some configurations, the center of the EAV 6516 may include a duckbill valve 6522 that can allow air to pass through the EAV 6516 in only one direction. The duckbill valve 6522 may block airflow in the opposite direction through the EAV 6516.

[0524] In some configurations, the EAV 6516 includes a membrane 6524 connecting a retaining flange 6520 to a duckbill valve 6522. The retaining flange 6520 may be the only part of the EAV 6516 fixed to the assembly, allowing the membrane 6524 to move in response to pressure differences acting on either side of the EAV 6516. While they may be formed as a single unit, the duckbill valve 6522 and the membrane 6524 may function independently of each other. The duckbill valve 6522 controls the airflow from the RPT device (e.g., blower 6502) to the patient interface (e.g., plenum chamber 6200), and the membrane 6524 controls the airflow from the patient interface (e.g., plenum chamber 6524) to the outlet vent 6414. The EAV 6516 may also be a dynamic component that responds to every breath the patient inhales.

[0525] In some forms, EAV 6516 is composed of a flexible material (e.g., silicone). EAV 6516 may be formed of LSR and / or CMSR. EAV 6516 may have a Shore hardness of 30 to 60 Shore(A).

[0526] As shown in Figures 33 and 34, the EAV 6516 may have a duckbill valve 6522 in the center of the membrane 6524. The duckbill valve 6522 may be a unidirectional valve that allows the membrane 6524 to pass in one direction. The pressure difference acting on either side of the duckbill valve 6522 determines whether the EAV 6516 is open or closed. The size and shape of the duckbill valve 6522 affect the flow rate and impedance through the membrane.

[0527] For example, as shown in Figure 33, the high pressure is located near the duckbill valve 6522, and the low pressure is located near the flange 6520. Due to the illustrated pressure difference, air is drawn towards the duckbill valve 6522 to reach the low pressure. However, the airflow comes into contact with the side (e.g., the outer surface) of the duckbill valve 6522, keeping the duckbill valve in the closed position.

[0528] Alternatively, as shown in Figure 34, the low pressure is located near the duckbill valve 6522 and the high pressure is located near the flange 6520. The illustrated pressure difference draws air toward the inner surface of the duckbill valve 6522 to reach the low pressure outside the duckbill valve 6522. Unlike in Figure 33, the flow in the direction shown in Figure 34 opens the duckbill valve 6522, allowing the high-pressure air to reach the low-pressure air.

[0529] As shown in Figure 35, the EAV 6516 may have a membrane 6524 that connects to the duckbill valve 6522 in the center, with its outer diameter (e.g., the portion close to the flange 6520). The membrane 6524 may be connected to the duckbill valve 6522 by a connecting section 6526 (e.g., a small flat section).

[0530] In one embodiment, the membrane 6524 has a trampoline-like ability to move up and down in response to a pressure difference acting on either side of the membrane 6524. The movement of the membrane 6524 does not affect the outer diameter (e.g., close to the protrusion 6520) and / or the shape or performance of the duckbill valve 6522.

[0531] In some configurations, the retaining flange 6520 may position the EAV 6516 relative to the manifold 6510. The retaining flange 6520 may also seal between the RPT device (e.g., blower 6502) and the mask air path (e.g., from manifold 6510 to inlet 6518), and between the RPT device and the outlet vent 6414. Unintended leaks (e.g., airflow generated by blower 6502 that does not reach the plenum chamber 6200) may be considered wasted effort and may affect the operation of the EAV 6516. When integrated, the retaining flange 6520 becomes the only part of the EAV 6516 fixed onto the assembly, thus allowing the membrane 6524 to move in response to pressure differences acting on either side.

[0532] In one embodiment, the technology includes a pressure sensor connected to a patient interface. A controller (e.g., a therapy device controller 4240) monitors the pressure within the patient interface measured by the pressure sensor and controls a pressure generator 4140 to adjust the flow rate of the generated air supply.

[0533] The retaining flange 6520 of the EAV 6516 may be located within a recess in a portion of the flow generator casing 6400 (e.g., the inlet 6518 of the rear case 6406). This feature ensures that the EAV 6516 is concentric with each component of the flow generator casing 6400 and restricts lateral movement.

[0534] When assembled, the retaining flange 6520 of the EAV 6516 forms an interference seal with the manifold 6510.

[0535] Section 6526 of the valve member membrane 6524 interfaced with the inlet 6518 may be aligned perpendicularly to the rib 6418 extending inward from the inlet 6518. The gap between the valve member membrane 6524 and the rib 6418 may control the flow in the periphery port. The holes of the outlet vent 6414 are larger and more open to the atmosphere than the gap. These can be considered secondary periphery ports and have less impact on the flow in the periphery port itself than the gap, but can provide more protective shroud for the valve member membrane 6524.

[0536] As shown in Figure 36, during inhalation, the pressure at the patient interface decreases due to the increase in volume caused by the contraction (descent) of the user's diaphragm. The pressure sensor records this change and signals the RPT device 6500 to provide more airflow to maintain the set CPAP pressure. The airflow from the RPT device increases the pressure on the RPT device side of the EAV 6516. This pressure is greater than the patient interface pressure (e.g., the pressure in the plenum chamber 6200) and moves the valve member membrane 6524 until it contacts the patient interface port rib 6418, reducing airflow loss. Simultaneously, the silicone duckbill valve 6522 opens, allowing air to flow into the plenum chamber 6200. This airflow increases the pressure at the patient interface until the desired CPAP pressure is reached.

[0537] In a specific configuration as shown in Figure 37, during inspiration, the RPT device 6500 receives a signal to provide an airflow to pressurize the plenum chamber 6200 and the user's airway. The airflow from the blower 6502 increases the pressure on the RPT device side of the EAV 6516. This pressure buildup causes the valve member membrane 6524 to move until it contacts the patient interface port rib 6418. Due to the pressure difference with the atmosphere, the valve member membrane 6524 remains in this position during inspiration, causing a loss of airflow and thus reduced efficiency.

[0538] In a specific configuration as shown in Figure 38, during intake, the pressure near the blower 6502 is greater than the pressure inside the plenum chamber 6200. The silicone duckbill valve 6522 opens, allowing air to flow into the plenum chamber 6200. This airflow increases the pressure inside the plenum chamber 6200 until it reaches the desired CPAP pressure.

[0539] As shown in Figure 39, during exhalation, the pressure in the plenum chamber 6200 increases due to the decrease in volume caused by the relaxation (upward movement) of the user's diaphragm. The pressure sensor records this change and signals the blower 6502 to stop or slow down. Thus, the pressure in the plenum chamber 6200 becomes greater than the pressure on the blower 6502 side of the EAV 6516, and the valve member membrane 6524 introduces an air channel (e.g., through the outlet vent 6414) away from the patient interface port rib 6418 to the atmosphere. At the same time, the duckbill valve 6522 closes to prevent the reverse airflow from returning towards the blower 6502 (e.g., through the manifold 6510). The pressure in the plenum chamber 6200 decreases as the airflow is released into the atmosphere (e.g., through the outlet vent 6414). The pressure sensor monitors this pressure drop, and the airflow from the blower 6502 remains off (or reduced) until the patient interface pressure falls below the set CPAP pressure.

[0540] In a specific configuration as shown in Figure 40, the pressure in the plenum chamber 6200 during exhalation is greater than the RPT device pressure (e.g., the pressure on the side of the EAV 6516 near the blower 6502). This pressure difference allows the valve member membrane 6524 to separate from the patient interface port rib 6418, introducing an airflow path to the atmosphere (e.g., through the outlet vent 6414). This gap 6420 is considered the primary periphery port of the EAV 6516 and has the greatest influence on the flow rate through the outlet vent 6414. The expelled airflow then flows into the chamber 6422 and exits through a secondary periphery port 6424, which may be formed in the rear case 6406 radially outside the inlet 6518. The periphery ports (e.g., gap 6420, secondary periphery port 6424, and outlet vent 6414) protect the EAV 6516 and shield it from foreign matter (e.g., backflow from debris).

[0541] In a specific configuration as shown in Figure 41, the silicone duckbill valve 6522 closes when the pressure in the plenum chamber 6200 is greater than the pressure in the suspension 6504. Therefore, the user's airflow during exhalation does not flow back into the manifold 6510 toward the blower 6502.

[0542] In certain configurations, the EAV 6516 dynamically moves between the inspiratory position (e.g., see Figures 36 to 38) and the expiratory position (e.g., see Figures 39 to 41) during the patient's respiratory cycle. The valve assembly is sometimes referred to as the expiratory-actuated valve (EAV), but it is constantly responding to all stages of the respiratory cycle, and the simplified illustrative diagrams in this document illustrate only extreme examples.

[0543] As highlighted above, the EAV 6500, in certain forms of technology, releases air into the atmosphere only during exhalation. Therefore, the vent flow curve may not follow the constant flow characteristics of conventional systems, but rather may follow an "on-off" curve shape. Since all possible ventilation flow is driven by the patient's effort, compared to conventional CPAP, the loss of ventilation flow during inspiration is reduced, and electrical and blower efficiency are improved.

[0544] In conventional patient interfaces, when a patient exhales, the pressure in the plenum chamber increases due to the increased air volume (pressure swing, etc.). This additional pressure is released through ventilation holes and simultaneously dissipated into the air circuit. Consequently, the internal volume of conventional patient interface systems is larger than that of systems of current technology. In some forms of this technology, the entire expiratory flow is discharged through a valve assembly. To mitigate the risk of pressure rise (swing), higher flow rates are enabled at the surrounding ports of the valve assembly, reducing impedance to the atmosphere.

[0545] As shown in Figures 42 to 47, the EAV 6516 may be designed in different shapes to achieve different impedances and / or deflections. The different shapes of the EAV 6516 may differ, but each may include similar functions as described above.

[0546] As shown in Figures 42 and 43, the first version of the EAV 6516-1 may include a flange 6520 that is substantially circular around its circumference. The duckbill valve 6522 may be located within the circumference of the flange 6520 (as described above) and may be substantially circular.

[0547] As shown in Figures 44 and 45, a second version of the EAV 6516-2 may include a substantially elliptical flange 6520. The duckbill valve 6522 may similarly have an elliptical shape.

[0548] As shown in Figures 46 and 47, the third version of EAV 6516-3 may include a substantially elliptical flange 6520. The duckbill valve 6522 may similarly have an elliptical shape. The elliptical shape of the third version 6516-3 may be more rounded than that of the second version 6516-2 (e.g., not elongated), but not perfectly circular like that of the first version 6516-1.

[0549] In some forms, different versions can be used to achieve different impedances. For example, an EAV with a more rounded shape (e.g., approximating a circle) may contain a higher impedance. Thus, the first version 6516-1 may contain the highest impedance, and the second version 6516-2 may contain the lowest impedance.

[0550] In some forms, different versions may also include different levels of deflection. For example, rounder versions (e.g., the first and third versions 6516-1, 6516-3) may include greater displacement of the membrane 6524 at a given pressure for both exhalation and inhalation.

[0551] As shown in Figure 52, the controller may determine the pressure in blower 6502 (e.g., before EAV 6516), the pressure in the plenum chamber 6200 (e.g., after EAV 6516), and the flow in blower 6502. The controller may use these data points to create a vent flow estimation model that can be used to estimate the vent flow rate (e.g., using the calculation in Figure 53). In some forms, the controller may control blower 6502 to optimize the ventilation flow. 5.6 Humidifier 5.6.1 Overview of Humidifiers

[0552] In one embodiment of this technology, a humidifier 5000 is provided (for example, as shown in Figure 5A) to alter the absolute humidity of the air or gas delivered to the patient relative to the surrounding air. Typically, the humidifier 5000 is used to increase the absolute humidity and raise the temperature of the airflow (compared to the surrounding air) before delivery to the patient's airway.

[0553] The humidifier 5000 may include a humidifier reservoir 5110, a humidifier inlet 5002 for receiving an airflow, and a humidifier outlet 5004 for delivering a humidified airflow. In some embodiments, such as those shown in Figures 5A and 5B, the inlet and outlet of the humidifier reservoir 5110 may be the humidifier inlet 5002 and the humidifier outlet 5004, respectively. The humidifier 5000 may further include a humidifier base 5006 adapted to house the humidifier reservoir 5110 and which may include a heating element 5240. 5.6.2 Humidifier components 5.6.2.1 Water Reservoir

[0554] In one configuration, the humidifier 5000 may include a water reservoir 5110 configured to receive or hold a certain volume of liquid, such as water, to evaporate for humidifying the airflow. The water reservoir 5110 may be configured to hold a predetermined maximum volume of water to provide adequate humidification for at least the duration of a respiratory therapy session, such as an overnight sleep. Typically, the reservoir 5110 is configured to hold several hundred milliliters of water (e.g., 300 milliliters (ml), 325 ml, 350 ml, or 400 ml). In other configurations, the humidifier 5000 may be configured to receive water from an external water source (e.g., a building's water supply system).

[0555] In one embodiment, the water reservoir 5110 is configured to humidify the airflow from the RPT device 4000 as the airflow passes through it. In one embodiment, the reservoir 5110 may be configured to encourage the air to pass through the reservoir 5110 in a meandering path while in contact with the amount of water in the reservoir 5110.

[0556] In one embodiment, the water reservoir 5110 can be removed laterally from the humidifier 5000, for example, as shown in Figures 5A and 5B.

[0557] The reservoir 5110 may also be configured to prevent liquid from flowing out when the reservoir 5110 is displaced and / or rotated, for example, through any opening and / or between its subcomponents, from its normal operating orientation. Since the airflow to be humidified by the humidifier 5000 is usually pressurized, the reservoir 5110 may also be configured to prevent air pressure loss due to leakage and / or flow impedance. 5.6.2.2 Conductive portion

[0558] In one configuration, the reservoir 5110 includes a conductive portion 5120 configured to allow efficient heat transfer from the heating element 5240 to a fixed volume of liquid in the reservoir 5110. In one embodiment, the conductive portion 5120 may be arranged as a plate, but other shapes may also be appropriate. The conductive portion 5120, in whole or in part, may consist of a thermally conductive material such as aluminum (e.g., with a thickness of approximately 2 mm (e.g., 1 mm, 1.5 mm, 2.5 mm, or 3 mm)), another thermally conductive metal, or some plastic. In some cases, a suitable thermal conductivity may be achieved by a less conductive material in a suitable shape. 5.6.2.3 Humidifier Reservoir Dock

[0559] In one embodiment, the humidifier 5000 may include a humidifier reservoir dock 5130 (as shown in Figure 5B) arranged to receive a humidifier reservoir 5110. In some configurations, the humidifier reservoir dock 5130 may include a locking mechanism such as a locking lever 5135 configured to hold the reservoir 5110 within the humidifier reservoir dock 5130. 5.6.2.4 Water level indicator

[0560] The humidifier reservoir 5110 may include a water level indicator 5150 as shown in Figures 5A-5B. In some forms, the water level indicator 5150 can provide a user, such as a patient 1000 or a caregiver, with one or more indications of the amount of water in the humidifier reservoir 5110. The one or more indications provided by the water level indicator 5150 may include an indication of the maximum predetermined volume of water, any portion thereof (e.g., 25%, 50%, or 75%), or a volume (e.g., 200 ml, 300 ml, or 400 ml). 5.6.2.5 Heating elements

[0561] In some cases, a heating element 5240 may be supplied to a humidifier 5000 to provide heat input to one or more of a certain volume of water and / or airflow in a humidifier reservoir 5110. The heating element 5240 may include heat-generating components such as an electrically resistive heating track. One suitable example of a heating element 5240 is a layered heating element, for example, described in PCT Patent Application Publication WO2012 / 171072, which is incorporated herein by reference in its entirety.

[0562] In some configurations, the heating element 5240 may be located within the humidifier base 5006, and heat may be supplied to the humidifier reservoir 5110 primarily by conduction, as shown in Figure 5B. 5.7 Respiratory waveform

[0563] Figure 6A shows a typical respiratory waveform model of a human during sleep. The horizontal axis represents time, and the vertical axis represents respiratory flow rate. While parameter values ​​can vary, typical respiration can approximate the following values: ventilation Vt 0.5 L, inspiratory time Ti 1.6 s, peak inspiratory flow rate Q peak 0.4 L / s, expiratory time Te 2.4 s, and peak expiratory flow rate Q peak -0.5 L / s. The total respiratory time Ttot is approximately 4 seconds. Typically, a person breathes at a rate of approximately 15 breaths per minute (BPM), and ventilation vent is approximately 7.5 L / min. The ratio of Ti to Ttot, which is a typical duty cycle, is approximately 40%. 5.8 Respiratory Therapy Modes

[0564] Various modes of respiratory therapy can be implemented by the disclosed respiratory therapy systems. 5.8.1 CPAP treatment

[0565] In some implementations of respiratory pressure therapy, the central controller 4230 sets the therapeutic pressure Pt according to the therapeutic pressure equation (1) as part of the therapy parameter determination algorithm 4329. In one such implementation, the amplitude A is also zero, and therefore, throughout the entire respiratory cycle, the therapeutic pressure Pt (representing the target value to be achieved at this point by the interface pressure Pm) is the same as the base pressure P0. Such implementations are mainly grouped under the heading of CPAP therapy. In such implementations, the therapy engine module 4320 does not need to determine the phase Φ or waveform template Π(Φ).

[0566] In CPAP therapy, the base pressure P0 may be a hardcoded constant value or a constant value manually entered into the RPT device 4000. Alternatively, the central controller 4230 can repeatedly calculate the base pressure P0 as a function of an indicator or measurement of sleep-disordered breathing, such as one or more of the following: flow limitation, apnea, hypopnea, patency, or snoring, which are returned by the corresponding algorithm in the therapy engine module 4320. This alternative therapy is sometimes called APAP therapy.

[0567] Figure 4E is a flowchart showing how method 4500 is performed by the central controller 4230 as part of the APAP therapy implementation of the therapy parameter determination algorithm 4329, when pressure assist A is also zero.

[0568] Method 4500 begins in step 4520, in which the central controller 4230 compares the measured value of apnea / hypopnea to a first threshold and determines whether the measured value of apnea / hypopnea has exceeded the first threshold indicating that apnea / hypopnea is occurring for a predetermined period of time. If so, Method 4500 proceeds to step 4540; otherwise, Method 4500 proceeds to step 4530. In step 4540, the central controller 4230 compares the measured value of airway patency to a second threshold. If the measured value of airway patency exceeds the second threshold indicating airway patency, the detected apnea / hypopnea is considered central and Method 4500 proceeds to step 4560; otherwise, the apnea / hypopnea is considered obstructive and Method 4500 proceeds to step 4550.

[0569] In step 4530, the central controller 4230 compares the flow limit measurement to a third threshold. If the flow limit measurement exceeds the third threshold, indicating that the intake airflow is being restricted, method 4500 proceeds to step 4550; otherwise, method 4500 proceeds to step 4560.

[0570] In step 4550, the central controller 4230 increases the base pressure P0 by a predetermined pressure increment ΔP, provided that the treatment pressure Pt does not exceed the maximum treatment pressure Pmax. In one implementation, the predetermined pressure increment ΔP and the maximum treatment pressure Pmax are 1 cmH2O and 25 cmH2O, respectively. In other embodiments, the pressure increment ΔP may be as low as 0.1 cmH2O and 3 cmH2O, or as low as 0.5 cmH2O and 2 cmH2O. In other embodiments, the maximum treatment pressure Pmax can be a minimum of 15 cmH2O and a maximum of 35 cmH2O, or a minimum of 20 cmH2O and a maximum of 30 cmH2O. The method then returns to step 4520.

[0571] In step 4560, the central controller 4230 lowers the base pressure Pmin, provided that the lowered base pressure P0 does not fall below the minimum treatment pressure P0. Then, method 4500 returns to step 4520. In one implementation, the amount of decrease is proportional to the value of P0-Pmin so that the decrease of P0 to the minimum treatment pressure Pmin is exponential, without any detected events. In one implementation, the proportionality constant is set such that the time constant τ for the exponential decrease of P0 is 60 minutes and the minimum treatment pressure Pmin is 4 cmH2O. In other implementations, the time constant τ can be a minimum of 1 minute and a maximum of 300 minutes, or a minimum of 5 minutes and a maximum of 180 minutes. In other implementations, the minimum treatment pressure Pmin can be a minimum of 0 cmH2O and a maximum of 8 cmH2O, or a minimum of 2 cmH2O and a maximum of 6 cmH2O. Alternatively, the amount of decrease of P0 can be predetermined, and therefore the decrease of P0 to the minimum treatment pressure Pmin without any detected events is linear. 5.8.2 Bilevel Therapy

[0572] In other implementations of this form of the technology, the value of amplitude 1 in equation (A) may be positive. This implementation is called bilevel therapy because, when equation (1) with a positive amplitude A is used to determine the therapeutic pressure Pt, the therapy parameter determination algorithm 4329 oscillates the therapeutic pressure Pt between two values ​​or levels in synchronization with the spontaneous respiratory effort of patient 1000. That is, based on the typical waveform template Π(Φ,t) above, the therapy parameter determination algorithm 4329 increases the therapeutic pressure Pt to P0+A (called IPAP) at the start of inspiration or during inspiration, and decreases the therapeutic pressure Pt to base pressure P0 (called EPAP) at the start of inspiration or during inspiration.

[0573] In one form of bilevel therapy, IPAP is the therapeutic pressure with the same purpose as the therapeutic pressure in CPAP therapy mode, while EPAP is IPAP minus amplitude A, which has a "smaller" value (some cmH2O) and is sometimes called expiratory pressure release (EPR). This form is also called CPAP therapy with EPR and is generally considered to be more comfortable than direct CPAP therapy. In CPAP therapy with EPR, either or both IPAP and EPAP can be constant values ​​and are hardcoded or manually entered into the RPT device 4000. Alternatively, the therapy parameter determination algorithm 4329 may iteratively calculate IPAP and / or EPAP during CPAP with EPR. In this alternative example, the therapy parameter determination algorithm 4329 iteratively calculates EPAP and / or IPAP as a function of the sleep-disordered breathing index or measurement returned from each algorithm in the therapy engine module 4320. This is done similarly to the calculation of the base pressure P0 in APAP therapy described above.

[0574] In other forms of bilevel therapy, the amplitude A is large enough for the RPT device 4000 to complete some or all of the patient's breathing motion. In this form, called pressure-assisted ventilation, the amplitude A is called pressure assist or swing. In pressure-assisted ventilation, IPAP is base pressure P0 + pressure assist A, and EPAP is base pressure P0.

[0575] In some forms of pressure-assisted ventilation known as constant-pressure assisted ventilation, the pressure assist A is fixed to a predetermined value, for example, 10 cmH2O. The predetermined pressure assist value is a setting of the RPT device 4000, which can be set, for example, by hardcoding during the configuration of the RPT device 4000 or by manual input through the input device 4220.

[0576] In other forms of pressure-assisted ventilation therapy, widely known as servo ventilation, the therapy parameter determination algorithm 4329 takes a constant currently measured or estimated parameter of the respiratory cycle (e.g., current measurement of ventilation vent) and a target value for the said respiratory parameter (e.g., target value of ventilation Vtgt) as inputs, and continuously adjusts the parameter in equation (1) to bring the current measurement of the respiratory parameter closer to the target value. In a form of servo ventilation called adaptive servo ventilation (ASV) used to treat CSR, the respiratory parameter is ventilation, and the target ventilation value Vtgt is calculated from a typical recent ventilation Vtyp by the target ventilation determination algorithm 4328, as described above.

[0577] In some forms of servo ventilation, the therapy parameter determination algorithm 4329 applies a control method that iteratively calculates pressure assist A to bring the current measured values ​​of respiratory parameters closer to target values. One such control method is proportional-integral (PI) control. In one implementation of PI control applied to an ASV mode where the target ventilation Vtgt is set slightly smaller than a typical ventilation Vtyp, pressure assist A is iteratively calculated as follows:

[0578]

number

[0579] Here, G is the gain of PI control. A larger value of gain G can result in positive feedback in the therapy engine module 4320. A smaller gain value G may leave untreated CSR or central sleep apnea. In some implementations, gain G is fixed at a predetermined value (e.g., -0.4 cmH2O / (L / min) / sec). Alternatively, gain G may be changed between therapy sessions (starting at a low value and increasing between sessions until a value that substantially eliminates CSR is reached). Conventional means for retrospectively analyzing therapy session parameters to assess the severity of CSR during therapy sessions may be used in such implementations. In other implementations, gain G may vary depending on the difference between the current measured ventilation value vent and the target ventilation value Vtgt.

[0580] Other servo ventilation control methods that can be applied by the treatment parameter determination algorithm 4329 include proportional (P), proportional-difference (PD), and proportional-integral-difference (PID).

[0581] The value of pressure assist A calculated by equation (2) can be extracted within the range defined as [Amin, Amax]. In this implementation, by default, pressure assist A is at the minimum pressure assist Amin until the current ventilation vent falls below the target ventilation Vtgt. At this point, A begins to increase and returns to Amin only when vent exceeds Vtgt again.

[0582] The pressure assist limits Amin and Amax are settings of the RPT device 4000, which are set, for example, by hardcoding during the configuration of the RPT device 4000 or by manual input through the input device 4220.

[0583] In pressure-assisted ventilation mode, EPAP is the base pressure P0. Similar to the base pressure P0 in CPAP therapy, EPAP can be a constant value defined or determined during titration. Such a constant EPAP can be set, for example, by hardcoding during the configuration of the RPT device 4000 or by manual input through the input device 4220. This alternative is also called fixed EPAP pressure-assisted ventilation therapy. Titration of EPAP for a given patient may be performed by a clinician during a titration session using PSG for the purpose of preventing obstructive apnea, thereby maintaining airway security for pressure-assisted ventilation therapy in a manner similar to the titration of base pressure P0 in constant CPAP therapy.

[0584] Alternatively, the therapy parameter determination algorithm 4329 may iteratively calculate the base pressure P0 during pressure-assisted ventilation therapy. In such an embodiment, the therapy parameter determination algorithm 4329 iteratively calculates EPAP as a function of sleep-disordered breathing indicators or measurements (e.g., one or more of flow limitation, apnea, respiratory depression, patency, and snoring) returned from each algorithm in the therapy engine module 4320. Because the continuous calculation of EPAP is analogous to the manual adjustment of EPAP by a clinician during EPAP titration, this process is also called automated titration of EPAP, and the therapy mode is known as automated titration EPAP pressure-assisted ventilation therapy or automated EPAP pressure-assisted ventilation therapy. 5.8.3 High flow therapy

[0585] In other forms of respiratory therapy, the airflow pressure is not controlled as in respiratory pressure therapy. Conversely, the central controller 4230 controls the pressure generator 4140 to deliver an airflow controlled by a therapeutic or target flow rate Qtgt, where the device flow rate Qd is typically positive throughout the patient's respiratory cycle. This form is usually grouped under the title of flow therapy. In flow therapy, the therapeutic flow rate Qtgt may be a hardcoded constant value or a constant value manually entered into the RPT device 4000. If the therapeutic flow rate Qtgt is sufficient to exceed the patient's peak inspiratory flow rate, this therapy is generally called high-flow therapy (HFT). Alternatively, the therapeutic flow rate may be a curve Qtgt(t) that changes according to the respiratory cycle. 5.9 AR / VR

[0586] Users may experience augmented reality (AR) and / or virtual reality (VR) by using a head-mounted display interface. Examples of head-mounted display interfaces are disclosed in International Publication No. 2021 / 137766, International Publication No. 2021 / 189096, U.S. Publication No. 2021 / 0302749, and U.S. Publication No. 2021 / 0302748, which are incorporated herein by reference, respectively.

[0587] As shown in Figures 54 and 55, the head-mounted display interface 11000 may include a user interface structure 11100, a display unit housing 11200, and a support structure 11300. The head-mounted display interface 11000 may output computer-generated images to the user wearing the head-mounted display interface 11000.

[0588] In some forms, the user interface structure 11100 may be made of a comfortable material (e.g., foam, textile, silicone, etc.) and may come into contact with the user's face. The user interface structure 11100 may help distribute the force applied to the user's face, making the head-mounted display interface 11000 more comfortable to wear.

[0589] The display unit housing 11200 may include electrical components for outputting computer-generated images. The display unit housing 11200 may be formed of a rigid or semi-rigid material to protect the electrical components.

[0590] The support structure 11300 may be similar to the positioning and stabilizing structures described above. For example, the support structure 11300 may include, in part, a strap made of a fibrous material. The strap may be stretched to accommodate users of various sizes. The strap may also be made rigid or stiff to obtain rigidity and / or stability.

[0591] The head-mounted display interface 1100 may include a battery (e.g., a rechargeable battery) within the display unit housing 11200. The head-mounted display interface may be detachably connected to a charger 6040 for charging the battery.

[0592] In other forms, the head-mounted display interface 11000 may include a port (not shown) for receiving a power cord 6020 connected to the battery 6010 (see, for example, Figure 23).

[0593] As shown in Figure 55, some forms of the head-mounted display interface 11000 may include at least one opening 11104 in the user interface structure 11000. When the user wears the head-mounted display interface 11000, at least one opening 11104 may be aligned with the user's nose. For example, a single opening may be aligned with both nostrils, or there may be separate openings for each nostril. The illustrated example also shows a user interface structure 11000 that supports the user's nose (similar to, for example, the seal-forming structure 8000 in Figure 17). Alternatively, the user interface structure 11000 may include a structure around at least one opening 11104 that is received within the user's nostrils.

[0594] The display unit housing 11200 may, in some forms, include a blower (e.g., similar to blower 6502, though not shown). The blower within the display unit housing 11200 may generate a flow of pressurized, breathable gas that can be output from at least one opening 11104. The patient may inhale the pressurized gas through their nose, as described in one of the examples above. Thus, the user interface structure 11000 can seal at least a portion of the user's face (e.g., to prevent leakage of pressurized air). Additionally, although not shown, the opening 11104 may extend around the user's mouth to allow the user to inhale pressurized air through their mouth.

[0595] In some forms, the head-mounted display interface 11000 may combine AR / VR and respiratory therapy functions. For example, a patient may use the head-mounted display interface 11000 to receive pressurized air to alleviate respiratory distress. Simultaneously, the user may view computer-generated images output from the display unit housing 11200. Utilizing AR / VR in therapy may make the therapy and patient interface more comfortable to wear (e.g., improving patient compliance). For example, computer-generated images may help the patient fall asleep more quickly to make the therapy more effective. Alternative examples

[0596] Figures 57–59 show a patient interface 12000 combining AR / VR and respiratory therapy features, based on an alternative example of the present technology. The patient interface 12000 may include a respiratory pressure therapy (RPT) device comprising: an electric blower 12050 configured to produce pressurized breathable air; a head-mounted display interface configured to produce computer-generated images to the patient; a user interface structure 12100 configured to engage with the patient's face; a flow generator casing 12200 (also called a display unit housing) at least partially surrounding the head-mounted display interface and the electric blower 12050; and a positioning and stabilization structure 12300 (also called a support structure) configured to maintain the user interface structure 12100 in a therapeutically effective position. In some forms, the head-mounted display interface may be a form of a head-mounted interface configured to substantially cover the patient's eyes. Such a head-mounted interface may not include either a display or a screen and may not produce any computer-generated images.

[0597] The flow generator casing 12200 is configured to support components associated with respiratory therapy (e.g., a blower 12050, one or more batteries (e.g., a pair of rechargeable batteries 12070) for powering the blower, and a treatment cushion component 12500) together with components associated with AR / VR (e.g., an electrical component for outputting computer-generated images, and a display interface having a stabilization cushion component 12700), see, for example, Figures 60-64. In one example, the respiratory therapy-related features may be integrated with existing space (e.g., the casing) occupied by the AR / VR features, i.e., there is a synergistic effect between respiratory therapy and AR / VR. Thus, in an example of this technology, the patient interface 12000 includes, together with the AR / VR system (e.g., the stabilization cushion component and the display interface), a built-in CPAP system (e.g., a treatment cushion component and an RPT device configured to deliver a pressurized, breathable airflow to the patient within a positive pressure range suitable for the treatment of respiratory diseases) to enhance the treatment (video and / or audio output). As described above, in some forms, a CPAP system can be configured such that the head-mounted interface does not include either a display or a screen, and does not generate any computer-generated images. 2-part cushion component

[0598] One embodiment of the present technology relates to a user interface structure for a patient interface configured to treat a patient with a respiratory disease, wherein the user interface structure includes a stabilization cushion component and a treatment cushion component separate from and distinct from the stabilization cushion component. In this example, the user interface structure 12100 of the interface includes a multi-part structure. For example, the user interface structure 12100 includes a two-part cushion component, namely a stabilization cushion component 12700 and a treatment cushion component 12500 separate from and distinct from the stabilization cushion component 12700, see, for example, Figures 66-73. The stabilization cushion component 12700 is configured to be detachably and interchangeably connected to a flow generator casing 12200, and the treatment cushion component 12500 is configured to be detachably and interchangeably connected to the stabilization cushion component 12700 and / or the flow generator casing 12200. This arrangement separates the sealing by the stabilization cushion component 12700 from the sealing by the treatment cushion component 12500, allowing them to be configured and designed independently for specific functions. For example, the stabilization cushion component 12700 could be configured to improve structure and stability for supporting the weight of the patient interface at the patient's face, while the treatment cushion component 12500 could be configured to improve sealing and comfort for respiratory therapy. Stability cushioning component

[0599] One embodiment of the present technology relates to a stabilization cushion component for a patient interface configured to treat a patient with a respiratory disease, wherein the stabilization cushion component is configured to extend around the patient's eyes. In one example, the stabilization cushion component 12700 extends around a display interface (e.g., a VR display) contained in a flow generator casing 12200 and is configured to form an acknowledgment opening for the display interface. During use, the stabilization cushion component 12700 extends around the user's eyes and engages with the user's face (e.g., along the user's cheeks and / or forehead), providing a substantially complete seal around the user's eyes (e.g., this allows at least partial blocking of light entering the flow generator casing 12200 to facilitate immersion of the display interface during use). Furthermore, the stabilization cushion component 12700 is configured and positioned to support the patient interface 12000 on the user's face in a comfortably stable manner.

[0600] The stability cushion component 12700 includes a chassis 12750 and a cushion 12775 configured to engage with the user's face. The chassis 12750 is relatively rigid compared to the cushion 12775. For example, the chassis may include polycarbonate, while the cushion may include foam and / or silicone, or other suitable materials.

[0601] The chassis 12750 is configured and positioned to repeatedly engage with and disengage from the flow generator casing 12200. In one example, the chassis 12750 may include one or more retaining parts (e.g., clips) around its periphery, configured to repeatedly and detachably engage with corresponding retaining parts provided on the flow generator casing 12200 when the stabilization cushion component 12700 is connected to the flow generator casing 12200. In one example, the retaining parts are substantially rigid so that the engagement between the retaining parts provides a firm connection.

[0602] The chassis 12750 can function as a base for the stabilization cushion component 12700, and can function, at least partially, as a base for the treatment cushion component 12500 when the treatment cushion component 12500 is connected to the stabilization cushion component 12700. Furthermore, the chassis 12750 can provide a certain degree of rigidity and the necessary structure to the stabilization cushion component 12700, and can also provide a certain degree of rigidity and the necessary structure to the treatment cushion component 12500.

[0603] In one example, the cushion 12775 includes a face contact portion configured to engage with the user's face, and a non-face contact portion configured to connect the cushion 12775 to the chassis 12750.

[0604] In one example, referring to Figures 74 and 75, the non-face contact portion includes a side wall 12780 provided on the chassis 12750, and a shelf-like portion 12785 configured to project inward from the side wall 12780 in a cantilever manner toward a confirmation opening. The face contact portion includes a membrane 12790, which includes a face engagement surface configured to bring the user's face into contact with the area around the user's eyes. The face contact portion also includes a foam cushion 12795. As shown, the membrane 12790 forms a loop, thereby covering the foam cushion 12795 with the membrane 12790 and its face engagement surface, and the foam cushion 12795 is positioned beneath the face engagement surface and surrounded by the membrane 12790. The non-face contact portion is configured to elastically support the foam cushion and membrane to apply reactive force when used on the user's face. For example, the shelf portion 12785 is configured to provide elastic spring-like supports for the foam cushion 12795 and membrane 12790. In one example, the side wall 12780, the shelf portion 12785, and the membrane 12790 include an elastomer material, such as silicone.

[0605] In another example, referring to Figures 76 and 77, the non-face contact portion includes a side wall 12780 provided on the chassis 12750, and a shelf portion 12785 configured to project outward from the side wall 12780 in a cantilever manner away from the confirmation opening. The face contact portion includes a foam cushion 12795, which includes a face engagement surface configured to bring the user's face into contact with the area around the user's eyes. The non-face contact portion is configured to elastically support the foam cushion to apply a reactive force when used on the user's face; for example, the shelf portion 12785 is configured to provide an elastic spring-like support to the foam cushion 12795. In one example, the side wall 12780 and the shelf portion 12785 include an elastomer material, such as silicone.

[0606] In one example, a foam cushion 12795 (e.g., polyurethane foam or viscoelastic foam) can be compressed at least partially against the user's face (e.g., through non-face contact areas) to conform to the contours of the user's face and support at least a portion of the weight of the patient interface. The foam cushion may be configured and positioned such that the compressive force or load applied to the user's face is distributed or diffused around the periphery of the face, so that the load is not concentrated at a minimum number of contact points. Furthermore, the foam cushion may include varying compliance (e.g., varying stiffness or density) around the periphery of the face, configured to allow for selective distribution of force onto the user's face. This arrangement allows for a higher level of pressure diffusion, spanning areas of the user's face that are more suitable for pressure absorption, such as the skull and sphenoid bone.

[0607] In one example, the foam cushion is configured to provide comfort, while the non-face-contact portion provides an elastic support structure (e.g., a bellows-type structure with at least one fold for stabilization and load-bearing capacity).

[0608] In one example, referring to Figures 76-77, the non-face contact portion is configured to form an outward concave deformation that facilitates the cushion bending outward during use, for example, a foam cushion 12795 oriented such that the face engagement surface flexes away from the confirmation opening during use.

[0609] In one example, one or more sensors may be provided on a stability cushion component (e.g., adjacent to the forehead) to detect deterioration of the component and suggest replacement, and / or provide a reminder to clean the component. Treatment Cushion Components

[0610] One embodiment of the present technology relates to a therapeutic cushion component for a patient interface configured to treat a patient with a respiratory disease, wherein the therapeutic cushion component is configured to form a plenum chamber and to form a seal with the patient's nose and / or mouth. In one example, the therapeutic cushion component 12500 is configured to form a seal with the user's nose and / or mouth and to deliver a pressurized, breathable airflow from a blower 12050 to the patient's nose and / or mouth. The therapeutic cushion component 12500 can be repeatedly and detachably engaged with a stabilization cushion component 12700 and / or a flow generator casing 12200.

[0611] In one example, the treatment cushion component 12500 includes a front portion 12550 and a cushion 12575 (also called a seal-forming structure) configured to form a seal against the patient's face, e.g., the patient's nose and / or mouth. The front portion 12550 and the cushion 12575 form at least a portion of an internal breathing chamber (plenum chamber) configured to receive pressurized air. The front portion 12550 is relatively rigid to the cushion 12575 (for example, the front portion contains polycarbonate and the cushion contains silicone). The front portion 12550 then forms an opening configured to communicate with a flow of pressurized gas from a flow generator casing and a blower.

[0612] The front portion 12550 may be permanently connected to the cushion 12575 (e.g., by commolding or overmolding) or detachably connected (e.g., by mechanical interlocking). In one example, the cushion is made of a relatively flexible or pliable material (e.g., silicone), and the front portion is made of a relatively rigid material (e.g., polycarbonate).

[0613] The front portion 12550 and cushion 12575 of the treatment cushion component can, as a whole, form a unit compatible with the stabilization cushion component 12700 and / or the flow generator casing 12200. That is, the treatment cushion component 12500 is repeatedly engageable with the stabilization cushion component 12700 and / or the flow generator casing 12200, and is removablely disengaged.

[0614] In one example, the stabilization cushion component 12700 may be offered in one size and / or type (e.g., one size fits most), but this may be used selectively with multiple sizes and / or types of treatment cushion components 12500. The treatment cushion component 12500 may be offered in two or more sizes and / or types (e.g., small, medium, and large sizes, such as silicone and / or foam cushions), including at least one aspect that is different from each other (e.g., cushions of different heights and / or widths, cushions of different materials). In an alternative example, the stabilization cushion component 12700 may also be offered in multiple sizes and / or types (e.g., silicone and / or foam cushions).

[0615] Each front portion 12550 of the different sizes / types of treatment cushion components 12500 includes a common or similar retaining part or interface for all sizes / types, thereby enabling the different sizes / types of treatment cushion components 12500 to connect or interface with a common stability component and / or flow generator casing. For example, a certain size or common stability cushion component can be connected or interfaced with each of the different sizes / types of treatment cushion components. That is, each treatment cushion component includes a common interlocking shape for all sizes / types.

[0616] In one example, the cushion 12575 of the treatment cushion component 12500 includes a nose cushion comprising a flexible membrane 12580 configured to seal around the patient's nose, and the sealing force (force vector) is positioned to extend substantially horizontally (e.g., substantially parallel to the Frankfoil horizontal plane). That is, the nose cushion is pulled toward the user's face (via the positioning and stabilization structure 12300) (and pulled back toward the user's face directly) under a suitable compressive force substantially coincided with the Frankfoil horizontal plane. Such a force vector substantially coincides with the force vector associated with the stabilization cushion component 12700, and such a force vector also substantially coincides with the Frankfoil horizontal plane. This arrangement simplifies use and adjustment when the force vectors for both the treatment cushion component 12500 and the stabilization cushion component 12700 are in the same plane, for example, the positioning and stabilization structure 12300 can simply include side straps positioned in the Frankfoil horizontal plane.

[0617] In one example, the treatment cushion component 12500 and the stabilization cushion component 12700 can have various compression ratios, for example, the treatment cushion may be softer or more flexible than the stabilization cushion, allowing for rapid deformation of the patient's facial contours for sealing during treatment.

[0618] Connection of treatment cushion component to stability cushion component In one example, referring to Figures 72 and 73, the treatment cushion component 12500 and the stability cushion component 12700 include a cooperative retaining structure that repeatedly and detachably connects the treatment cushion component 12500 to the stability cushion component 12700. In one example, the treatment cushion component 12500 is detachably connectable to the stability cushion component 12700, facilitating replacement and / or cleaning, and allowing alternative treatment cushion components 12500 and stability cushion components 12700 to be connected to each other. Such an arrangement allows multiple treatment cushion components 12500 (e.g., different sizes and / or types) to be used with the stability cushion component 12700, thus providing a user interface structure 12100 suitable for most users.

[0619] In one example, the chassis 12750 of the stabilization cushion component 12700 (composed of a relatively rigid plastic material, such as polycarbonate) provides an interface with the treatment cushion component 12500. For example, the front portion 12550 of the treatment cushion component 12500 includes retaining parts configured and positioned to repeatedly and detachably engage retaining parts provided on the chassis 12750 of the stabilization cushion component 12700 when the treatment cushion component 12500 connects with the stabilization cushion component 12700. In one example, the retaining parts are substantially rigid such that the engagement between the retaining parts provides a robust connection, for example, by a snap-fit ​​connection (e.g., repeatedly engageable and detachable).

[0620] In one example, the outer edge and / or shape of the front portion of the treatment cushion component is configured to facilitate alignment of the front portion with the chassis of the stability cushion component for engagement. For example, the shape of the front portion may be asymmetrical to minimize misalignment.

[0621] In one example, when the treatment cushion component and the stability cushion component engage, accidental disengagement of the retaining part is prevented from occurring due to the structure or shape of the retaining part; that is, the retaining part is configured to maintain engagement during use and prevent any unintended or partial disassembly during use.

[0622] In one example, the treatment cushion component connects with the stability cushion component to provide a substantially immovable assembly that substantially withstands adjustable movement between the treatment cushion component and the stability cushion component. manifold

[0623] In one example, a manifold 12400 (composed of a relatively rigid plastic material such as polycarbonate) is provided on the chassis 12750 (e.g., integrally molded) of the stabilization cushion component 12700, and the manifold 12400 provides an interface or retaining structure with the treatment cushion component 12500; see, for example, Figures 72 and 73. The manifold 12400 is hollow and configured to form an airflow path to assist in transporting a pressurized, breathable airflow from the blower 12050 of the treatment cushion component 12500 to the internal breathing chamber.

[0624] As shown in the figure, the manifold 12400 includes a first opening 12410 and a second opening 12420 oriented substantially perpendicular to the first opening 12410, thereby allowing the manifold to change the direction of the airflow. For example, the airflow path may move downward through the first opening in Figure 29 before moving backward through the second opening.

[0625] The first opening 12410 is configured to communicate with the inside of the flow generator casing 12200 and its blower 12050, and the second opening 12420 is configured to communicate with the treatment cushion component 12500 (see, for example, Figure 75). When the treatment cushion component 12500 is connected to the stabilization cushion component 12700, the retaining flange defines the second opening 12420 and forms at least a portion of the retaining part provided on the front portion 12550 of the treatment cushion component 12500, configured to engage the retaining part repeatedly and detachably.

[0626] In one embodiment, the treatment cushion component 12500 may be engaged with and disengaged from the stability cushion component 12700 by moving the treatment cushion component 12500 substantially in the front-to-back direction toward the stability cushion component 12700; see, for example, Figure 73. However, engagement and disengagement may include alternative directions, for example, depending on the retaining structure.

[0627] When the treatment cushion component 12500 is connected to the stabilization cushion component 12700, the treatment cushion component 12500 and the stabilization cushion component 12700 as a whole can form a unit compatible with the flow generator casing 12200, see, for example, Figure 72. That is, the stabilization cushion component 12700, and the treatment cushion component 12500 connected thereto, are repeatedly engageable with and detachably disengaged from the flow generator casing 12200.

[0628] Furthermore, when the stabilization cushion component 12700 is connected to the flow generator casing 12200, the treatment cushion component 12500 is repeatably engageable with the stabilization cushion component 12700 and detachably disengaged from the stabilization cushion component 12700, which may allow, for example, the treatment cushion component 12500 to be removed while the stabilization cushion component 12700 remains connected to the flow generator casing 12200.

[0629] In another example, the manifold 12400 may form a separate and distinct structure from the stabilization cushion component 12700. In this example, the manifold 12400 may be removably connected to the treatment cushion component 12500, so that the manifold 12400 and the treatment cushion component 12500 as a whole may form a unit compatible with the flow generator casing 12200 and / or the stabilization cushion component 12700, see, for example, Figures 67-71. For example, the manifold 12400 may include a cooperative retaining structure that repeatedly and detachably connects the manifold 12400 to the flow generator casing 12200 and / or the stabilization cushion component 12700 (along the treatment cushion component 12500).

[0630] In one example, the manifold 12400 (alongside the treatment cushion component 12500) and the stabilization cushion component 12700 may be independently and repeatedly and detachably engaged with the flow generator casing 12000.

[0631] In one embodiment, the stabilization cushion component 12700 may be engageable with / disengaged from the flow generator casing 12000 by moving the stabilization cushion component 12700 toward the flow generator casing 12000 substantially in a longitudinal direction, and the treatment cushion component 12500 may be engageable with / disengaged from the flow generator casing 12000 by moving the treatment cushion component 12500 toward the flow generator casing 12000 substantially in a vertical direction; see, for example, Figure 70. That is, the assembly directions of the stabilization cushion component 12700 and the treatment cushion component 12500 may be different from each other, for example, lateral. However, engagement / disengagement may include alternative directions, for example, depending on the retaining structure. EAV

[0632] In one example, the expiratory-actuated valve (EAV) 12800 is positioned adjacent to the manifold 12400 and the treatment cushion component 12500, controlling the airflow to the treatment cushion component 12500; see, for example, Figures 71, 73, and 75. As described above, the EAV 12800 includes a one-way duckbill valve configured to open during the patient's inspiration, directing pressurized gas from the blower 12050 of the treatment cushion component 12500 into the breathing chamber, and to close during the patient's expiration, preventing backflow of airflow to the blower 12050 while the EAV 12800 introduces the airflow path from the breathing chamber to the atmosphere for ventilation. Without departing from the scope of the example, it should be understood that other types of valves may replace the EAV.

[0633] In the example, as shown in Figures 71, 73, and 75, the manifold 12400 and front portion 12550 of the treatment cushion component 12500 cooperate to accommodate the EAV 12800, for example, each of the manifold and front portion at least partially receiving, positioning, and / or holding in place a portion of the EAV.

[0634] In the illustrated example, the treatment cushion component 12500 is repeatedly engageable with and detachably disengaged from the manifold 12400, thereby allowing the EAV 12800 to be removed for replacement and / or cleaning.

[0635] In one embodiment, the EAV12800 can be integrated with the treatment cushion component 12500 (for example, the EAV12800, manifold 12400, and treatment cushion component 12500 form a unit), thereby making the EAV12800 and treatment cushion component 12500 interchangeable as a unit; see, for example, Figures 67-71. Flow generator casing

[0636] In one example, referring to Figures 65-69, the flow generator casing 12200 includes a front case 12210 and a rear case 12220, which work together to house and support components for respiratory therapy and AR / VR. The flow generator casing 12200 may also include, for example, an enclosure plate 12230 for housing an inlet filter, an air outlet opening, an air inlet opening, an air outlet

[0637] In one example, the rear case 12220 includes a two-part connection, namely a first component 12221 and a second component 12222 connected to the first component 12221.

[0638] In one example, the rear side of the first component 12221 of the rear case includes one or more retaining parts (e.g., clips) around its periphery, configured to repeatedly and detachably engage with corresponding retaining parts provided on the chassis 12770 of the stability cushion component 12700 when the stability cushion component 12700 is connected to the flow generator casing 12200.

[0639] In one example, the lower portion of the first part 12221 is configured to be positioned and / or to hold, at least partially, a treatment cushion component 12500 and / or a portion of the manifold 12400. For example, the lower portion of the first part 12221 may form a recess having a cooperative holding structure that repeatedly and detachably connects the flow generator casing 12200 to the flow generator casing 12200 (along the treatment cushion component 12500).

[0640] The second part 12222 of the rear case forms a cavity located in and / or configured to receive, at least partially receive, the blower 12050. In one example, the upper part of the cavity is configured to hold the blower 12050, and the lower part of the cavity communicates with the central outlet of the blower 12050. When connected, the second part 12222 works in cooperation with the first part 12221 to form a volute that transports a pressurized breathable airflow from the blower 12050 to the manifold 12400 (and then to the treatment cushion component 12500), see, for example, Figures 74-75.

[0641] As described above, the blower 12050 has a substantially cylindrical shape and forms a parallel stage arrangement, and the blower 12050 includes at least one pair of impellers coupled to a common shaft and arranged in parallel. That is, the blower 12050 includes inlets on each side of the blower, each having a corresponding impeller, which together create a parallel flow of air passing through the blower, achieving a desired flow at the central outlet.

[0642] In one example, a suspension may be provided within the rear case 12220 to receive and elastically support the blower 12050. In one example, the second component 12222 includes a retaining wall having a corresponding opening configured to align with one of the corresponding inlets of the blower 12050.

[0643] In one example, the second component 12222 of the rear case is configured to be located therein and / or to hold, at least partially, a portion of a battery, for example, to power the blower and / or electronics of the AR / VR. For example, in the illustrated example, the second component 12222 is configured to hold two batteries 12070, i.e., one battery 12070 positioned on each side of the blower 12050. As illustrated, each battery 12070 includes a substantially cylindrical shape, and each side of the second component 12222 may include a rounded retaining structure configured to hold one of the corresponding batteries 12070.

[0644] The front case 12210 is connected to the rear case 12220 (for example, detachably), so that the front case 12221 surrounds the second component 12222 and substantially covers another side of the first component 12221. As a result, the front and rear cases work together to house and hold the blower, battery, display interface; as well as the electronics associated with the blower and display interface.

[0645] In one example, the front case, rear case, and / or enclosure plate may include one or more inlet openings for receiving ambient air to be delivered to the blower. For example, Figures 78-79 show an example in which the inlet opening 12231 is provided in the enclosure plate 12230. In one example, such intake airflow may pass at least partially along and / or through the user interface structure, at least partially cooling the user interface structure, which may have a beneficial effect on sleep.

[0646] In one example, an inhalation airflow and / or a pressurized airflow from a blower may have alternative uses in respiratory therapy, such as for cooling cushions, immersive gaming, or aromatherapy.

[0647] In one example, the front case and / or rear case may include one or more outlet openings (ventilation openings) for exhausting respiratory therapy air to the surroundings. In one example, the front case and / or rear case may form an exhaust channel communicating with the EAV, allowing exhaled air to pass around the EAV, enter the exhaust channel, and pass through one or more ventilation openings.

[0648] In one example, one or more pressure sensors may be supported within the flow generator casing 12200 and monitor pressure associated with respiratory therapy, for example, adjacent to a blower, adjacent to a treatment cushion component. Positioning and stabilization structure

[0649] In one example, the positioning and stabilization structure 12300 can be adjusted and detachably connected to at least a portion of the flow generator casing 12200 for holding the patient interface 12000 in an operable position on the patient's face.

[0650] In one example, as shown in Figures 57-59, the positioning and stabilizing structure 12300 may include a single side strap 12310 that extends along the side of the patient's head and passes through the corresponding ear, configured to facilitate dressing and adjustment, for example. The side strap 12310 may include ends that are adjustablely connected to each side of the flow generator casing 12200 (via mechanical fasteners, hooks and look materials, magnets, etc.). In one example, each side of the flow generator casing 12200 may include a crossbar that forms a strap opening, to which strap connectors, for example, each end of the side strap, are screwed.

[0651] In one example, one or more strap connectors for the positioning and stabilization structure 12300 may be provided on the front case 12210, rear case 12220, and / or enclosure plate 12230 of the flow generator casing 12200. Two-piece cushion for full-face patient interface

[0652] In one example, the two-part cushion structure is applicable to the seal-forming structure of the full-face patient interface for respiratory therapy described above, for example, the seal-forming structure 6100 in Figure 31.

[0653] For example, as shown in Figures 80-83, the seal-forming structure 6100 may include a two-part cushion component, namely a nasal cushion component 6100 and a separate and different mouth cushion component 6120. The nasal cushion component 6110 is configured to be detachably and interchangeably connected to the casing 6408, while the mouth cushion component 6120 is configured to be detachably and interchangeably connected to the casing 6408 independently of the nasal cushion component 6100. This configuration separates the seal provided by the mouth cushion component 6120 from the seal provided by the nasal cushion component 6100, allowing them to be configured and selected independently for specific functions. For example, the mouth cushion component may be configured to improve structure and stability for supporting the weight of the interface on the patient's face, while the nasal cushion component may be configured to improve sealing and comfort for respiratory therapy.

[0654] In one example, the nasal cushion component 6100 is configured to form a seal with the patient's nose (i.e., around the patient's nostrils) and deliver a pressurized, breathable airflow from the blower to the patient's nose. For example, the nasal cushion component 6100 may seal around the patient's nostrils while avoiding contact with the patient's nasal bridge.

[0655] In one example, the mouth cushion component 6120 may include a foam cushion configuration similar to that described above in relation to the stability cushion component 12700, for example, the mouth cushion component 6120 may include a foam cushion elastically supported by a non-face contact portion. In one example, the mouth cushion component may be configured to form a seal around at least a portion of the patient's mouth, for example, the nose cushion component may be configured to form a seal along the patient's upper lip / upper part of the patient's mouth.

[0656] In one example, the patient interface is configured so that pressurized breathable air from the blower is delivered only to the patient's nose via the nasal cushion component 6100. In an alternative example, the patient interface may be configured so that pressurized breathable air is delivered to both the patient's nose and mouth via both the nasal cushion component and the mouth cushion component.

[0657] This two-part configuration allows for the connection of various sizes / types of nose cushion components and / or mouth cushion components to the casing, as well as the removal of the nose cushion components and / or mouth cushion components for replacement and / or cleaning.

[0658] In an alternative example, the nose cushion component may be releasably connectable to the mouth cushion component, so that the nose cushion component and the mouth cushion component as a whole may form a unit compatible with the casing. 5.10 Audio

[0659] As shown in Figure 56, a patient interface and audio system 6800 may be used. For example, patient interface 8000 is shown, but audio system 6800 may be used with any patient interface. In addition, audio system 6800 may be used with a head-mounted display interface 11000.

[0660] In some configurations, the patient interface 8000 may include an alternative positioning and stabilization structure 8375, which may include a front strap 8376, similar to the front strap 6304. For example, the illustrated front strap 8376 may be connected (e.g., permanently or detachably) to the flow generator casing 6400. The positioning and stabilization structure 8375 is shown with the audio system 6800, but can also be used without the audio system 6800.

[0661] In certain configurations, the positioning and stabilization 8376 may include a hoop 8378 connected to a front strap 8376. The hoop 8378 may extend around the patient's head from the patient's frontal bone to the patient's occipital bone. In the illustrated example, the hoop 8378 may be made of a continuous material, but in other examples, it may include multiple materials that allow for adjustment of the length of the hoop 8378.

[0662] In some configurations, the front strap 8376 is adjustable relative to the hoop 8378, allowing the patient to change the angle of the front strap 8376 relative to the hoop 8378 (for example, so that the patient can find a comfortable fit).

[0663] In some configurations, the audio system 6800 may be connected to a positioning and stabilization structure 8375. For example, the audio system 6800 may be connected to a hoop 8378. The audio system 6800 may be located inside the hoop 8378 so that a patient wearing the patient interface 8000 can come into contact with the audio system 6800.

[0664] In some forms, the audio system 6800 includes a pair of output devices 6804. Each output device 6804 may output sound to one of the patient's ears. In the illustrated example, the output bus 6804 is formed as an earmuff and may be placed over and / or surround each of the patient's ears. In other examples (not shown), the output device 6804 may be an earphone that fits into the patient's ear.

[0665] In certain configurations, the output device 6804 may output noise to the patient using the patient interface 8000. For example, the patient may play music, white noise, or any sound of their choice. The sound output from the output device 6804 may help the patient relax while using the patient interface 8000 (for example, to fall asleep faster and stay asleep).

[0666] In certain configurations, the user may use the audio system 6800 without using the patient interface 8000. For example, Japanese Patent Application No. PCT / SG2021 / 050590 describes an example without a patient interface for supplying pressurized air, which is incorporated herein by reference in its entirety.

[0667] In some embodiments, the power cord 6020 may be connected to the front strap 8376 of the positioning and stabilization structure 8375. In other embodiments, the power cord 6020 may be connected to the flow generator casing 8400, or the patient interface 8000 may include a removable battery (e.g., battery 6030 or battery 6035). 5.11 Glossary

[0668] For the purposes of disclosing this technology, one or more of the following definitions may apply in certain forms of this technology. In other forms of this technology, alternative definitions may apply. 5.11.1 Overview

[0669] Air: In certain forms of this technology, air may be considered to mean the atmosphere, and in other forms of this technology, air may be considered to mean other combinations of some breathable gases, such as oxygen-enriched air.

[0670] Surroundings: In certain forms of this technology, the term surroundings is considered to mean (i) outside the treatment system or patient, and (ii) directly surrounding the treatment system or patient.

[0671] For example, the ambient humidity for a humidifier could be the humidity of the air directly surrounding the humidifier, such as the humidity of the room where the patient is sleeping. Such ambient humidity may differ from the humidity outside the room where the patient is sleeping.

[0672] In another example, ambient pressure could be pressure directly surrounding or outside the body.

[0673] In certain forms, ambient (e.g., acoustic) noise can be considered the background noise level in the patient's room, excluding noise originating from, for example, the RPT device or from the mask or patient interface. Ambient noise may originate from sound sources outside the room.

[0674] Automatic Positive Airway Pressure (APAP) therapy: CPAP therapy that can automatically adjust the therapeutic pressure between minimum and maximum limits between breaths, for example, depending on the presence or absence of signs of SDB onset.

[0675] Continuous positive airway pressure (CPAP) therapy is a respiratory pressure therapy in which the therapeutic pressure remains nearly constant throughout the patient's respiratory cycle. In some forms, the pressure at the airway entrance increases slightly during exhalation and decreases slightly during inhalation. In some forms, the pressure fluctuates between different respiratory cycles of the patient (for example, increasing in response to the detection of signs of partial upper airway obstruction and decreasing if signs of partial upper airway obstruction are not present).

[0676] Flow rate: The amount (or mass) of air discharged per unit time. Flow rate can refer to an instantaneous quantity. In some cases, when flow rate is mentioned, it refers to a scalar quantity (i.e., a quantity that has only magnitude). In other cases, a reference to flow rate is a reference to a vector quantity (i.e., a quantity that has both magnitude and direction). Flow rate may be denoted by the symbol Q. "Flow rate" is sometimes simply written as "flow" or "airflow".

[0677] In the case of patient respiration, the flow rate may be nominally positive for the inspiratory portion of the patient's respiratory cycle, and therefore negative for the expiratory portion. Device flow rate Qd is the flow rate of air exiting the RPT device. Total flow rate Qt is the flow rate of air reaching the patient interface via the air circuit, plus any supplemental gases. Exhaust flow rate Qv is the flow rate of air exiting the exhaust port to expel exhaled gases. Leakage flow rate Ql is the flow rate leaking from the patient interface system, etc. Respiratory flow rate Qr is the flow rate of air received by the patient's respiratory system.

[0678] Flow therapy is a respiratory therapy that involves delivering air to the airway entrance at a controlled flow rate called therapeutic flow rate, which is typically positive throughout the patient's entire respiratory cycle.

[0679] Humidifier: A humidifier is understood as a humidifying device that has a physical structure capable of supplying a therapeutically beneficial amount of water (H2O) vapor to the airflow in order to improve a patient's medical respiratory condition, and is arranged or configured accordingly.

[0680] Leakage: The term "leakage" refers to an unintended airflow. In one embodiment, leakage may occur as a result of an incomplete seal between the mask and the patient's face. In another embodiment, leakage may occur at the elbow relative to the surroundings.

[0681] Conducted Noise (Acoustics): In this document, conducted noise refers to noise transmitted to a patient via pneumatic pathways (e.g., air circuits and patient interfaces and the air within them). In one form, conducted noise can be quantified by measuring the sound pressure level at the end of the air circuit.

[0682] Noise Radiation (Acoustic): In this document, radiated noise refers to noise transmitted to the patient by the surrounding air. In one form, radiated noise can be quantified by measuring the acoustic power / pressure level of the object in question according to ISO 3744.

[0683] Ventilation (acoustic) noise: In this specification, ventilation noise refers to noise generated by airflow passing through any ventilation opening, such as a ventilation hole in the patient interface.

[0684] Oxygen-enriched air: Air with a higher oxygen concentration than the atmosphere (21%), such as at least approximately 50%, at least approximately 60%, at least approximately 70%, at least approximately 80%, at least approximately 90%, at least approximately 95%, at least approximately 98%, or at least approximately 99% oxygen. "Oxygen-enriched air" is sometimes abbreviated to "oxygen."

[0685] Medical oxygen: Medical oxygen refers to oxygen-enriched air with an oxygen concentration of 80% or higher.

[0686] Patient: A person, regardless of whether they have a respiratory illness or not.

[0687] Pressure: Force per unit area. Pressure is expressed as cmH2O, gf / cm². 2 It can be expressed in a variety of units, including hectopascals. 1 cmH2O is 1 g-f / cm³. 2 This is equivalent to approximately 0.98 hectopascals (1 hectopascal = 100 Pa = 100 N / m³). 2 (=1 millibar to 0.001 atm). Unless otherwise specified, pressure is given in cmH2O.

[0688] The pressure in the patient interface is denoted with Pm, and the therapeutic pressure, which indicates the target value to be achieved at the present time for the mask pressure Pm, is denoted with Pt.

[0689] Respiratory pressure therapy: Typically involves supplying air to the airway opening at a positive therapeutic pressure relative to atmospheric pressure.

[0690] Ventilator: A mechanical device that provides pressure assistance to a patient to perform some or all of the breathing function. 5.11.1.1 Materials and their properties

[0691] (Durometer hardness (indentation hardness): A material property measured by the indentation of an indenter (measured according to ASTM D2240).

[0692] • "Soft" materials may include silicone or thermoplast...

Claims

1. A patient interface for treating patients with respiratory diseases, A respiratory pressure therapy (RPT) device including an electric blower configured to generate pressurized, breathable air, A user interface structure configured to engage with the patient's face, the user interface structure comprising at least partially forming a plenum chamber configured to receive the pressurized breathable air, A head-mounted interface configured to substantially cover the patient's eyes, A flow generator casing that at least partially encloses the head-mounted interface and the electric blower and is connected to the plenum chamber, the flow generator casing includes at least one air opening for receiving ambient air to be delivered to the RPT device, The user interface structure includes a positioning and stabilizing structure configured to maintain the user interface structure in a therapeutically effective position, The user interface structure includes a stability cushion component and a treatment cushion component that is separate from and different from the stability cushion component. The stabilizing cushion component is configured to extend primarily around the patient's eyes and to form a confirmation opening for the head-mounted interface. The treatment cushion component is configured to form the plenum chamber and to form a seal with the patient's nose and / or mouth. A patient interface comprising a stabilization cushion component configured to be detachably and interchangeably connected to the flow generator casing, and a treatment cushion component configured to be detachably and interchangeably connected to the stabilization cushion component and / or the flow generator casing.

2. The patient interface according to claim 1, wherein the stabilizing cushion component is configured to engage with the patient's face and provide a substantially complete seal around the patient's eyes.

3. The patient interface according to claim 2, wherein the stabilizing cushion component includes a chassis and a cushion configured to engage with the patient's face, the chassis being configured and positioned to repeatedly engage with and disengage from the flow generator casing.

4. The patient interface according to claim 3, wherein the chassis is relatively harder than the cushion.

5. The patient interface according to any one of claims 3 to 4, wherein the cushion includes a face contact portion configured to engage with the patient's face and a non-face contact portion configured to connect the cushion to the chassis.

6. The patient interface according to claim 5, wherein the face contact portion includes a foam cushion configured to bring the patient's face into contact with the area around the user's eyes.

7. The patient interface according to claim 5, wherein the face contact portion includes a silicone film, the face contact portion including a face engagement surface configured to bring the patient's face into contact with the area around the user's eyes.

8. The non-face contact portion includes a side wall provided on the chassis and a shelf-like portion configured to protrude away from the side wall in a cantilever manner, and the non-face contact portion is configured to have an elastic spring-like support provided on the face contact portion, according to any one of claims 5 to 7.

9. The patient interface according to any one of claims 3 to 8, wherein the chassis of the stability cushion component provides an interface with the treatment cushion component.

10. The patient interface according to claim 9, wherein the interface includes a manifold configured to form an airflow path for transporting the pressurized breathable air from the blower to the treatment cushion component.

11. The patient interface according to any one of claims 1 to 8, wherein the treatment cushion component is configured to be detachably and interchangeably connected to the flow generator casing.

12. The patient interface according to any one of claims 1 to 11, wherein the treatment cushion component includes a front portion and a cushion configured to form a seal with the patient's nose and / or mouth.

13. The patient interface according to claim 12, wherein the front portion is relatively harder than the cushion.

14. The patient interface according to any one of claims 12 to 13, wherein the cushion is a nasal cushion comprising a silicone membrane configured to form a seal with the patient's nose.

15. The patient interface according to any one of claims 1 to 14, wherein the stabilization cushion component is provided in one size and / or type, and the treatment cushion component is provided in multiple sizes and / or types.

16. The patient interface according to any one of claims 1 to 15, further comprising a manifold configured to form an airflow path for transporting the pressurized breathable air from the blower to the treatment cushion component.

17. The patient interface according to claim 16, wherein the manifold and the treatment cushion component cooperate to house an expiratory-operated valve (EAV) that, during inhalation, directs the pressurized breathable air from the blower to the treatment cushion component, and during exhalation, directs the pressurized breathable air from the treatment cushion component to an exhaust channel.

18. The patient interface according to any one of claims 1 to 17, wherein the blower includes at least one pair of impellers coupled to a common shaft and arranged in parallel.

19. The patient interface according to any one of claims 1 to 18, further comprising a pair of batteries supported by the flow generator casing on each side of the blower.

20. The positioning and stabilization structure is connected to at least a portion of the flow generator casing, according to any one of claims 1 to 19.

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